A Phase 2 interventional study of Anti-Hypertensive medications and Dry Weight Adjustment in Blood Pressure, End Stage Renal Disease on Dialysis (Diagnosis) and Chronic Kidney Diseases, sponsored by University of California, San Francisco. Completed at 2 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-07-03.
Sponsored by University of California, San Francisco · Phase 2, Interventional, and Treatment
Blood pressure may be one of the most important modifiable risk factors for cardiovascular disease in patients with end-stage-renal-disease undergoing maintenance hemodialysis. Although a systolic blood pressure \<140 mmHg treatment target has been recommended, there remains uncertainty on which blood pressure should be targeted, more specifically that measured in the dialysis unit or at home. Observational studies have reported a paradoxical U-shaped associated with dialysis unit (pre-dialysis) systolic blood pressure and cardiovascular events and death (where blood pressure below 140 mmHg is actually linked with poor outcomes). Conversely, the same studies have reported a linear association between higher home systolic blood pressure and worse clinical outcomes, where blood pressure below 140 mmHg is associated with better outcomes. This pilot clinical trial aims to address this important question.
Blood Pressure Lowering in Dialysis (BOLD) is a pilot randomized controlled trial of 50 maintenance hemodialysis patients in San Francisco and Seattle to test whether targeting a home systolic blood pressure \<140 mmHg (versus a pre-dialysis systolic blood pressure \<140 mmHg) is feasible and safe. The study duration is 4 months and blood pressure targets will be achieved through dry weight adjustment and adjustment of standard anti-hypertensive therapies by the study team. The primary outcomes are focused on feasibility and safety. The home blood pressure treatment arm will also have the opportunity to utilize a blood pressure monitor with Bluetooth capabilities. The rates of utilization of mobile health technology in this population will also be assessed as an outcome. This pilot trial will provide key data to design a larger trial focused on clinical outcomes.
University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be asked to take morning and evening blood pressures every two weeks on a non-dialysis day. Participants will be asked to transmit these measures to the study team at minimum every 2 weeks either via Bluetooth technology, a manual log, telephone call, text message, e-mail, or verbal communication. Assigned intervention will be dry weight adjustment and/or adjustment of standard anti-hypertensive medications.
Drug: Anti-Hypertensive medications · Procedure: Dry Weight Adjustment
Blood pressures taken in the clinical setting at prior to start of dialysis treatment will be recorded. Assigned intervention will be dry weight adjustment and/or adjustment of standard anti-hypertensive medications.
Drug: Anti-Hypertensive medications · Procedure: Dry Weight Adjustment
Use of standard Anti-Hypertensive medications
Also known as: anti-hypertensive
The participant's target post-dialysis dry weight is adjusted
Feasibility - Screen:Enrollment Ratio
Percentage of eligible participants screened and eventually enrolled in the study
Time frame: Screening
Adherence to Assigned Treatment Arm
Percentage of participants in the home blood pressure (BP) arm who are able to measure home BP and transmit readings to the research team. Overall, across 16 wks.
Time frame: 4 months
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
1. Postdialysis unit systolic BP \<90 mmHg 2. Postdialysis unit systolic BP \>200 mmHg 3. Cramping during dialysis 4. Syncope episodes 5. Episodes of fall 6. Episodes of flash pulmonary edema 7. Symptoms of dizziness
Time frame: Assessed every 2 weeks over 4 months
Mean Duration (in Minutes) of Recovery From Dialysis Treatments
Data were reported at study visits every 2 wks, the mean was calculated from the first to the last follow-up visit. The mean was calculated for each participant, then the overall mean was calculated for each arm.
Time frame: Assessed every 2 weeks; Data averaged over 16 weeks
| Milestone | Home Systolic Blood Pressure (SBP) <140 mmHg | Pre-dialysis SBP <140 mmHg |
|---|---|---|
| Started | 25 | 25 |
| Completed | 25 | 24 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal due to transplant | 0 | 1 |
Percentage of eligible participants screened and eventually enrolled in the study
| Participants | Participants Screened |
|---|---|
| Feasibility - Screen:Enrollment Ratio | 50 |
Percentage of participants in the home blood pressure (BP) arm who are able to measure home BP and transmit readings to the research team. Overall, across 16 wks.
| percentage of participants | Home Systolic Blood Pressure (SBP) <140 mmHg |
|---|---|
| 0 BP Readings | 3 |
| 1 BP Reading | 4 |
| 2 BP Readings | 93 |
1. Postdialysis unit systolic BP \<90 mmHg 2. Postdialysis unit systolic BP \>200 mmHg 3. Cramping during dialysis 4. Syncope episodes 5. Episodes of fall 6. Episodes of flash pulmonary edema 7. Symptoms of dizziness
| Participants | Home Systolic Blood Pressure (SBP) <140 mmHg | Pre-dialysis SBP <140 mmHg |
|---|---|---|
| Postdialysis unit systolic BP <90 mmHg | 2 | 0 |
| Postdialysis unit systolic BP >200 mmHg | 3 | 2 |
| Cramping during dialysis | 13 | 18 |
| Syncope episodes | 1 | 1 |
| Episodes of fall | 3 | 6 |
| Episodes of flash pulmonary edema | 0 | 0 |
| Symptoms of dizziness | 10 | 14 |
Data were reported at study visits every 2 wks, the mean was calculated from the first to the last follow-up visit. The mean was calculated for each participant, then the overall mean was calculated for each arm.
| Minutes | Home Systolic Blood Pressure (SBP) <140 mmHg | Pre-dialysis SBP <140 mmHg |
|---|---|---|
| Mean Duration (in Minutes) of Recovery From Dialysis Treatments | 327 ± 42 | 268 ± 37 |
Collected over 16 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Home Systolic Blood Pressure (SBP) <140 mmHg | 0/25 (0%) | 2/25 (8%) | 25/25 (100%) |
| Dialysis SBP <140 mmHg | 0/25 (0%) | 1/25 (4%) | 25/25 (100%) |
| Event | Home Systolic Blood Pressure (SBP) <140 mmHg | Dialysis SBP <140 mmHg |
|---|---|---|
| SyncopeCardiac disorders | 2/25 | 1/25 |
| Event | Home Systolic Blood Pressure (SBP) <140 mmHg | Dialysis SBP <140 mmHg |
|---|---|---|
| Intradialytic hypotensionCardiac disorders | 21/25 | 18/25 |
| CrampingMusculoskeletal and connective tissue disorders | 13/25 | 18/25 |
| Symptoms of fatigueGeneral disorders | 15/25 | 16/25 |
| Symptoms of dizzinessGeneral disorders | 10/25 | 14/25 |
| Symptoms of lightheadednessGeneral disorders | 14/25 | 12/25 |
| FallGeneral disorders | 3/25 | 6/25 |
| Predialysis SBP > 200 mm HgCardiac disorders | 4/25 | 4/25 |
| Postdialysis SBP > 200 mm HgCardiac disorders | 3/25 | 2/25 |
| Predialysis SBP < 90 mm HgCardiac disorders | 1/25 | 2/25 |
| Postdialysis SBP < 90 mm HgCardiac disorders | 2/25 | 0/25 |
| Age, Continuous(years) | Home Systolic Blood Pressure (SBP) <140 mmHg | Pre-dialysis SBP <140 mmHg | Total |
|---|---|---|---|
| Mean | 56.4 ± 13.1 | 56.9 ± 14.4 | 56.6 ± 13.6 |
| Sex: Female, Male(Participants) | Home Systolic Blood Pressure (SBP) <140 mmHg | Pre-dialysis SBP <140 mmHg | Total |
|---|---|---|---|
| Female | 12 | 8 | 20 |
| Male | 13 | 17 | 30 |
| Race (NIH/OMB)(Participants) | Home Systolic Blood Pressure (SBP) <140 mmHg | Pre-dialysis SBP <140 mmHg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 6 | 5 | 11 |
| Native Hawaiian or Other Pacific Islander | 1 | 2 | 3 |
| Black or African American | 11 | 9 | 20 |
| White | 6 | 8 | 14 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(participants) | Home Systolic Blood Pressure (SBP) <140 mmHg | Pre-dialysis SBP <140 mmHg | Total |
|---|---|---|---|
| United States | 25 | 25 | 50 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Dec 2018, 8 months.
Results were first posted in Jul 2023, 4 years 6 months after primary completion.
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