An observational study in Hypertension and Blood Pressure, sponsored by Abbott Medical Devices. Terminated at 33 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-27.
Sponsored by Abbott Medical Devices · Observational
The purpose of this post market clinical investigation is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled hypertension.
This is a post market, prospective, multicenter, non-randomized, single arm study of the EnligHTN™ Renal Denervation System. Approximately 500 subjects with uncontrolled hypertension will undergo renal artery ablation at approximately 40 investigational sites located internationally and will be followed up to five years post procedure.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 276 is above the median of 210 across 1,359 observational studies indexed under Hypertension.
Browse Hypertension studies →Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects with uncontrolled hypertension
Exclusion Criteria:
* Office systolic Blood Pressure ≥160 mmHg * Subject is taking ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Patient has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula
Device: EnligHTN
* Office systolic Blood Pressure ≥140 mmHg * Subject is taking ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Patient has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula
Device: EnligHTN
* Office systolic Blood Pressure ≥140 mmHg * Subject is taking ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Patient has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula
Device: EnligHTN
Renal artery ablation with EnligHTN system used for all groups
Mean Reduction in Office Systolic Blood Pressure From Baseline to 6 Months
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
Time frame: Baseline to 6 months
Acute Safety: Percentage of Participants With Peri-procedural Events Within 30 Days Post-procedure
The peri-procedural events occurring within 30 days post procedure were summarized as the percentage of the number of participants with peri-procedural events within 30 days post procedure compared to the number of participants at baseline for that population.
Time frame: 30 days post procedure
Midterm Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 6 Months
The new renal artery stenosis (\>50%) and/or aneurysm at the site of ablation per Renal Artery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed on the time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.
Time frame: 6 months
Midterm Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 6 Months
Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.
Time frame: Confirmatory visit to 6 months
Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 2 Years
The new renal artery stenosis (\>50%) and/or aneurysm at the site of ablation per RenalArtery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed onthe time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.
Time frame: 2 years
Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 5 Years
The new renal artery stenosis (\>50%) and/or aneurysm at the site of ablation per RenalArtery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed onthe time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.
Time frame: 5 years
Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 2 Years
Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.
Time frame: Confirmatory visit to 2 years
Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 5 Years
Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.
Time frame: Confirmatory visit to 5 years
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 6 Months
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
Time frame: Baseline to 6 months
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 6 Months
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
Time frame: Baseline to 6 months
Mean Change in Office Diastolic Blood Pressure From Baseline to 6 Months
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
Time frame: Baseline to 6 months
Percentage of Participants Achieved Office Systolic Blood Pressure < 140 mmHg at 6 Months
The percentage of participants achieved office systolic blood pressure \<140 mmHg at 6 months visit was computed as the percentage of the ratio of number of participants who achievied office systolic blood pressure \<140 mmHg at 6 months visit to the number of participants with data available in 6 months visit.
Time frame: 6 months
Mean Change in Office Systolic Blood Pressure From Baseline to 1 Year Post Denervation
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
Time frame: Baseline to 1 year
Mean Change in Office Systolic Blood Pressure From Baseline to 2 Years Post Denervation
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
Time frame: Baseline to 2 years
Mean Change in Office Systolic Blood Pressure From Baseline to 3 Years Post Denervation
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
Time frame: Baseline to 3 years
Mean Change in Office Systolic Blood Pressure From Baseline to 4 Years Post Denervation
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
Time frame: Baseline to 4 years
Mean Change in Office Systolic Blood Pressure From Baseline to 5 Years Post Denervation
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
Time frame: Baseline to 5 years
Mean Change in Office Diastolic Blood Pressure From Baseline to 1 Year Post Denervation
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
Time frame: Baseline to 1 year
Mean Change in Office Diastolic Blood Pressure From Baseline to 2 Years Post Denervation
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
Time frame: Baseline to 2 years
Mean Change in Office Diastolic Blood Pressure From Baseline to 3 Years Post Denervation
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
Time frame: Baseline to 3 years
Mean Change in Office Diastolic Blood Pressure From Baseline to 4 Years Post Denervation
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
Time frame: Baseline to 4 years
Mean Change in Office Diastolic Blood Pressure From Baseline to 5 Years Post Denervation
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
Time frame: Baseline to 5 years
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 1 Year Post Denervation
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
Time frame: Baseline to 1 year
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 2 Years Post Denervation
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
Time frame: Baseline to 2 years
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 3 Years Post Denervation
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
Time frame: Baseline to 3 years
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 4 Years Post Denervation
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
Time frame: Baseline to 4 years
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 5 Years Post Denervation
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
Time frame: Baseline to 5 years
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 1 Year Post Denervation
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
Time frame: Baseline to 1 year
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 2 Years Post Denervation
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
Time frame: Baseline to 2 years
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 3 Years Post Denervation
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
Time frame: Baseline to 3 years
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 4 Years Post Denervation
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
Time frame: Baseline to 4 years
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 5 Years Post Denervation
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
Time frame: Baseline to 5 years
A total of 276 subjects who underwent renal artery ablation fell into the analysis population of three predefined arms at 33 investigational sites located throughout Europe and Australia. The enrollment began on January 2013 and the last subject was enrolled on 06 September, 2016. The patients last follow-up visit occurred on 27 November, 2019.
| Milestone | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Started | 147 | 101 | 28 |
| Renal artery ablation procedure | 147 | 101 | 28 |
| Discharge following renal artery ablation procedure | 147 | 100 | 28 |
| Completed | 72 | 49 | 12 |
| Not completed | 75 | 52 | 16 |
| Withdrew: Missed visit | 10 | 4 | 1 |
| Withdrew: Death | 4 | 4 | 6 |
| Withdrew: Withdrawal by subject | 61 | 44 | 9 |
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
| mmHg | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Baseline | 179.9 ± 22.3 | 160.8 ± 17.9 | 177.1 ± 22.7 |
| 6 Months | 163.2 ± 25.1 | 147.9 ± 17.2 | 158.7 ± 21.9 |
| Change from baseline to 6 months | -16.7 ± 26.7 | -12.9 ± 21.8 | -18.3 ± 25.8 |
The peri-procedural events occurring within 30 days post procedure were summarized as the percentage of the number of participants with peri-procedural events within 30 days post procedure compared to the number of participants at baseline for that population.
| Participants | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Acute Safety: Percentage of Participants With Peri-procedural Events Within 30 Days Post-procedure | 49 | 37 | 8 |
The new renal artery stenosis (\>50%) and/or aneurysm at the site of ablation per Renal Artery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed on the time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.
| Participants | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Midterm Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 6 Months | 0 | 0 | 0 |
Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.
| mL/min/1.73m^2 | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Confirmatory visit | 80.2 ± 20.2 | 78.6 ± 17.6 | 35.3 ± 8.2 |
| 6 months | 79.5 ± 24.7 | 79.6 ± 19.6 | 41.3 ± 12.7 |
| Change from confirmatory visit to 6 months | -0.7 ± 14.4 | 1.1 ± 13.5 | 5.9 ± 11.6 |
The new renal artery stenosis (\>50%) and/or aneurysm at the site of ablation per RenalArtery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed onthe time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.
| Participants | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 2 Years | 2 | 2 | 0 |
The new renal artery stenosis (\>50%) and/or aneurysm at the site of ablation per RenalArtery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed onthe time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.
| Participants | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 5 Years | 3 | 2 | 0 |
Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.
| mL/min/1.73m^2 | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Confirmatory visit | 79.4 ± 17.4 | 78.4 ± 19.0 | 36.3 ± 8.2 |
| 2 years | 76.4 ± 21.6 | 77.7 ± 19.0 | 41.1 ± 14.1 |
| Change from confirmatory visit to 2 years | -3.0 ± 15.8 | -0.7 ± 14.9 | 4.8 ± 13.2 |
Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.
| mL/min/1.73 m^2 | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Confirmatory visit | 77.6 ± 14.7 | 80.8 ± 17.2 | 38.6 ± 7.5 |
| 5 years | 67.9 ± 20.0 | 77.0 ± 18.6 | 37.5 ± 16.5 |
| Change from confirmatory visit to 5 years | -9.7 ± 17.3 | -3.8 ± 15.7 | -1.1 ± 14.5 |
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
| mmHg | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Baseline | 158.3 ± 15.7 | 147.0 ± 12.1 | 160.4 ± 18.9 |
| 6 months | 151.2 ± 18.2 | 142.7 ± 17.3 | 152.2 ± 15.9 |
| Change from baseline to 6 months | -7.1 ± 16.5 | -4.3 ± 17.1 | -8.1 ± 24.6 |
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
| mmHg | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Baseline | 88.8 ± 12.7 | 86.8 ± 14.3 | 83.3 ± 15.8 |
| 6 months | 85.5 ± 12.1 | 83.0 ± 12.5 | 78.1 ± 13.9 |
| Change from baseline to 6 months | -3.3 ± 9.3 | -3.8 ± 13.4 | -5.1 ± 13.1 |
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
| mmHg | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Baseline | 97.0 ± 16.2 | 91.2 ± 13.6 | 91.0 ± 13.3 |
| 6 months | 89.6 ± 15.6 | 86.0 ± 13.4 | 77.9 ± 14.4 |
| Change from baseline to 6 months | -7.4 ± 13.9 | -5.2 ± 12.2 | -13.1 ± 10.1 |
The percentage of participants achieved office systolic blood pressure \<140 mmHg at 6 months visit was computed as the percentage of the ratio of number of participants who achievied office systolic blood pressure \<140 mmHg at 6 months visit to the number of participants with data available in 6 months visit.
| Participants | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Percentage of Participants Achieved Office Systolic Blood Pressure < 140 mmHg at 6 Months | 19 | 27 | 4 |
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
| mmHg | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Baseline | 180.0 ± 22.4 | 160.1 ± 17.6 | 176.8 ± 23.0 |
| 1 year | 166.4 ± 25.6 | 147.8 ± 20.8 | 159.8 ± 26.6 |
| Change from baseline to 1 year | -13.6 ± 26.6 | -12.3 ± 22.6 | -17.0 ± 28.7 |
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
| mmHg | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Baseline | 178.7 ± 22.0 | 158.5 ± 16.6 | 178.0 ± 22.4 |
| 2 years | 160.6 ± 26.5 | 144.3 ± 19.5 | 153.1 ± 17.5 |
| Change from baseline to 2 years | -18.1 ± 29.0 | -14.2 ± 20.9 | -24.8 ± 27.0 |
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
| mmHg | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Baseline | 179.3 ± 21.9 | 160.7 ± 17.5 | 179.0 ± 23.7 |
| 3 years | 159.1 ± 28.5 | 143.8 ± 19.4 | 151.2 ± 21.3 |
| Change from baseline to 3 years | -20.2 ± 34.1 | -16.9 ± 23.1 | -27.8 ± 28.1 |
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
| mmHg | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Baseline | 177.7 ± 21.8 | 157.6 ± 15.4 | 180.4 ± 24.1 |
| 4 years | 156.2 ± 28.8 | 144.6 ± 25.3 | 146.9 ± 23.5 |
| Change from baseline to 4 years | -21.5 ± 35.4 | -13.0 ± 24.9 | -33.5 ± 24.4 |
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
| mmHg | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Baseline | 176.2 ± 20.3 | 160.2 ± 16.3 | 184.8 ± 24.6 |
| 5 years | 151.8 ± 22.6 | 144.4 ± 21.8 | 152.8 ± 19.1 |
| Change from baseline to 5 years | -24.4 ± 28.4 | -15.7 ± 24.8 | -32.0 ± 25.7 |
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
| mmHg | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Baseline | 97.8 ± 16.6 | 91.0 ± 13.5 | 91.5 ± 13.3 |
| 1 year | 90.9 ± 17.6 | 85.5 ± 13.7 | 78.5 ± 14.2 |
| Change from baseline to 1 year | -6.9 ± 15.0 | -5.5 ± 13.2 | -13.0 ± 13.3 |
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
| mmHg | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Baseline | 97.1 ± 16.8 | 91.0 ± 12.7 | 92.0 ± 12.9 |
| 2 years | 88.2 ± 16.6 | 83.4 ± 13.0 | 75.2 ± 14.3 |
| Change from baseline to 2 years | -8.9 ± 16.5 | -7.6 ± 12.3 | -16.8 ± 14.7 |
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
| mmHg | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Baseline | 98.6 ± 17.5 | 92.0 ± 13.2 | 91.3 ± 13.3 |
| 3 years | 87.1 ± 15.8 | 82.9 ± 12.8 | 76.6 ± 14.8 |
| Change from baseline to 3 years | -11.5 ± 18.4 | -9.0 ± 12.6 | -14.7 ± 14.5 |
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
| mmHg | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Baseline | 97.5 ± 17.5 | 91.0 ± 12.7 | 93.2 ± 11.2 |
| 4 years | 86.2 ± 13.5 | 85.2 ± 16.3 | 77.2 ± 12.3 |
| Change from baseline to 4 years | -11.3 ± 18.2 | -5.9 ± 13.4 | -16.0 ± 9.8 |
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
| mmHg | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Baseline | 98.4 ± 17.3 | 93.1 ± 12.8 | 95.8 ± 13.0 |
| 5 years | 84.9 ± 11.7 | 85.1 ± 16.1 | 78.7 ± 12.7 |
| Change from baseline to 5 years | -13.4 ± 14.4 | -8.0 ± 14.5 | -17.1 ± 14.0 |
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
| mmHg | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Baseline | 159.1 ± 16.1 | 146.8 ± 11.4 | 163.9 ± 18.8 |
| 1 year | 149.0 ± 18.7 | 141.7 ± 17.3 | 148.2 ± 21.1 |
| Change from baseline to 1 year | -10.1 ± 18.3 | -5.1 ± 16.8 | -15.8 ± 24.3 |
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
| mmHg | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Baseline | 158.5 ± 15.8 | 146.7 ± 11.8 | 159.9 ± 16.8 |
| 2 years | 148.0 ± 17.2 | 139.5 ± 15.0 | 144.0 ± 16.7 |
| Change from baseline to 2 years | -10.5 ± 18.6 | -7.2 ± 16.0 | -15.9 ± 18.7 |
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
| mmHg | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Baseline | 157.8 ± 15.9 | 147.0 ± 11.9 | 156.0 ± 14.8 |
| 3 years | 144.2 ± 19.3 | 139.8 ± 18.1 | 151.2 ± 18.8 |
| Change from baseline to 3 years | -13.6 ± 21.5 | -7.2 ± 18.8 | -4.8 ± 20.5 |
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
| mmHg | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Baseline | 157.2 ± 14.5 | 146.3 ± 11.7 | 158.4 ± 16.4 |
| 4 years | 142.3 ± 19.6 | 137.9 ± 19.1 | 151.6 ± 21.2 |
| Change from baseline to 4 years | -14.9 ± 22.4 | -8.5 ± 17.8 | -6.8 ± 29.6 |
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
| mmHg | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Baseline | 155.2 ± 14.9 | 143.7 ± 9.8 | 158.0 ± 18.1 |
| 5 years | 140.0 ± 17.8 | 133.3 ± 13.4 | 146.3 ± 26.3 |
| Change from baseline to 5 years | -15.1 ± 22.0 | -10.4 ± 11.8 | -11.7 ± 33.4 |
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
| mmHg | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Baseline | 89.1 ± 12.9 | 86.2 ± 14.1 | 85.4 ± 16.3 |
| 1 year | 84.7 ± 12.0 | 81.9 ± 12.2 | 77.7 ± 12.2 |
| Change from baseline to 1 year | -4.4 ± 10.4 | -4.4 ± 13.4 | -7.6 ± 14.1 |
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
| mmHg | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Baseline | 88.6 ± 13.2 | 86.6 ± 14.2 | 84.6 ± 16.9 |
| 2 years | 83.8 ± 12.0 | 81.5 ± 11.4 | 76.9 ± 14.8 |
| Change from baseline to 2 years | -4.8 ± 10.4 | -5.0 ± 12.3 | -7.6 ± 10.8 |
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
| mmHg | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Baseline | 89.0 ± 12.9 | 87.7 ± 14.7 | 81.7 ± 14.7 |
| 3 years | 81.3 ± 11.2 | 81.2 ± 12.9 | 76.8 ± 12.9 |
| Change from baseline to 3 years | -7.7 ± 13.8 | -6.5 ± 13.9 | -4.9 ± 10.5 |
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
| mmHg | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Baseline | 88.4 ± 12.5 | 87.6 ± 14.8 | 82.1 ± 14.1 |
| 4 years | 80.3 ± 12.5 | 80.9 ± 13.4 | 78.1 ± 12.6 |
| Change from baseline to 4 years | -8.1 ± 14.6 | -6.6 ± 14.5 | -4.0 ± 11.6 |
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
| mmHg | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Baseline | 87.1 ± 13.1 | 87.9 ± 15.6 | 83.2 ± 14.8 |
| 5 years | 79.2 ± 10.7 | 78.5 ± 11.1 | 76.0 ± 14.4 |
| Change from baseline to 5 years | -7.8 ± 12.6 | -9.4 ± 13.1 | -7.2 ± 13.1 |
Collected over 5 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| A - EnligHTN for Severe Resistant HTN | 4/147 (2.7%) | 72/147 (49%) | 40/147 (27.2%) |
| B - EnligHTN for Resistant HTN | 4/101 (4%) | 38/101 (37.6%) | 26/101 (25.7%) |
| C - EnligHTN for Resistant HTN & CKD | 6/28 (21.4%) | 18/28 (64.3%) | 9/28 (32.1%) |
| Event | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| Heart FailureCardiac disorders | 4/147 | 2/101 | 3/28 |
| Myocardial InfarctionCardiac disorders | 5/147 | 5/101 | 3/28 |
| Atrial FibrillationCardiac disorders | 3/147 | 3/101 | 2/28 |
| Chest PainCardiac disorders | 7/147 | 4/101 | 2/28 |
| PneumoniaInfections and infestations | 3/147 | 1/101 | 2/28 |
| Renal FailureRenal and urinary disorders | 0/147 | 1/101 | 2/28 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/147 | 0/101 | 2/28 |
| Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders | 3/147 | 0/101 | 2/28 |
| Arterial Hypertension/HypertensionVascular disorders | 10/147 | 5/101 | 2/28 |
| StrokeNervous system disorders | 7/147 | 3/101 | 0/28 |
| Event | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD |
|---|---|---|---|
| VasospasmVascular disorders | 15/147 | 12/101 | 1/28 |
| VASC BruiseVascular disorders | 3/147 | 2/101 | 2/28 |
| VASC DrainageVascular disorders | 9/147 | 3/101 | 0/28 |
| VASC HematomaVascular disorders | 5/147 | 5/101 | 1/28 |
| VASC PainVascular disorders | 7/147 | 5/101 | 1/28 |
| Renal Artery StenosisVascular disorders | 7/147 | 2/101 | 0/28 |
| Angina PectorisCardiac disorders | 0/147 | 0/101 | 1/28 |
| Colon PolypsGastrointestinal disorders | 0/147 | 0/101 | 1/28 |
| PneumoniaInfections and infestations | 0/147 | 0/101 | 1/28 |
| HypokalemiaMetabolism and nutrition disorders | 0/147 | 0/101 | 1/28 |
Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
| Age, Continuous(years) | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD | Total |
|---|---|---|---|---|
| Mean | 61.6 ± 10.0 | 58.0 ± 11.8 | 68.5 ± 8.0 | 60.9 ± 10.9 |
| Sex: Female, Male(Participants) | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD | Total |
|---|---|---|---|---|
| Female | 64 | 26 | 10 | 100 |
| Male | 83 | 75 | 18 | 176 |
| Race and Ethnicity Not Collected(Participants) | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Office Blood Pressure(mmHg) | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD | Total |
|---|---|---|---|---|
| Systolic | 180.4 ± 22.3 | 160.8 ± 17.5 | 177.3 ± 22.3 | 172.9 ± 22.6 |
| Diastolic | 97.1 ± 16.3 | 91.2 ± 13.3 | 90.6 ± 13.2 | 94.3 ± 15.2 |
| 24-hour ambulatory blood pressure(mmHg) | A - EnligHTN for Severe Resistant HTN | B - EnligHTN for Resistant HTN | C - EnligHTN for Resistant HTN & CKD | Total |
|---|---|---|---|---|
| Systolic | 159.0 ± 16.3 | 147.4 ± 12.3 | 161.8 ± 19.3 | 155.0 ± 16.3 |
| Diastolic | 88.9 ± 13.1 | 87.0 ± 14.4 | 82.9 ± 15.6 | 87.6 ± 13.9 |
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