A Phase 4 interventional study of Eplerenone and Telmisartan in Hypertension (HTN) and Low-Renin Essential Hypertension, sponsored by China National Center for Cardiovascular Diseases. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by China National Center for Cardiovascular Diseases · Phase 4, Interventional, and Treatment
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Among 25 studies testing eplerenone in Hypertension — 6 open to participants now, 6 under way, none of them phase 3. Eplerenone · Hypertension.
Among the 25 studies testing eplerenone in Hypertension, this one is the 8th largest by planned enrollment, is one of 2 that started in 2026, is one of 14 in phase 4, and was the 25th registered.
6,118 studies on the registry are indexed under Hypertension; 914 are open to participants now.
Browse Hypertension studies →6 of the 25 studies testing eplerenone in Hypertension are open now, in 4 countries. Recruiting first, the newest first:
Massachusetts General Hospital · Sites in United States
Ages 18–65 · Women only
National Institute of Cardiology, Warsaw, Poland · Sites in Poland
Ages 18–65
Hippocration General Hospital · Sites in Greece
Ages 30–75
Brigham and Women's Hospital · Sites in United States
Ages 18–75
Brigham and Women's Hospital · Sites in United States
Ages 18–85
By country, each count listing its studies:
Eplerenone: first FDA approval 2002 (INSPRA). What it is approved for, and how studies give it, is on its page →
Of the 562 Hypertension studies recruiting now, 266 (47%) set no upper age limit and 200 (36%) stop at 75 or younger; 40 take children under 18; 138 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
25 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 128 is above the median of 100 across 4,579 interventional studies indexed under Hypertension.
Median enrollment 60 across the 25 interventional studies. Of the 14 that completed or were terminated, 3 (21%) have results posted.
This tab as a report to print or save as PDF → With an account.
6 of 25 have an industry lead sponsor. The 10 most frequent:
China National Center for Cardiovascular Diseases is the lead sponsor of 270 studies on the registry; 142 are open to participants now.
17 studies in Hypertension by China National Center for Cardiovascular Diseases: 8 open now, 9 under way, none of them phase 3. Of 4 finished, 0 (0%) have results posted.
Among the 17 studies in Hypertension by China National Center for Cardiovascular Diseases, this one is the 13th largest by planned enrollment of the 16 interventional ones that give a count, is one of 3 that started in 2026, is one of 3 in phase 4, and was the 17th registered.
China National Center for Cardiovascular Diseases’s Hypertension studies by the year they started, since 2012.
2 of the studies testing eplerenone in Hypertension that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05593055Brigham and Women's HospitalMineralocorticoid Receptor, Coronary Microvascular Function, and Cardiac Efficiency in Hypertension | 2027-04-01 |
| NCT05030545Brigham and Women's HospitalCardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study | 2027-10-31 |
Add all 2 to your calendar (.ics) → With an account.
Among the 25 studies testing eplerenone in Hypertension, from their registry updates:
Among China National Center for Cardiovascular Diseases’s 17 in Hypertension:
This tab as a report to print or save as PDF → With an account.
This study aims to evaluate the efficacy and safety of early initiation of eplerenone, a second-generation mineralocorticoid receptor antagonist, compared with standard antihypertensive treatment in adults with low-renin essential hypertension. The study will assess whether an eplerenone-based treatment strategy provides greater blood pressure reduction, improves blood pressure control, and reduces antihypertensive medication burden compared with standard treatment.
The EMERALD Trial is a prospective, randomized, open-label, controlled study designed to compare the efficacy and safety of early initiation of a second-generation mineralocorticoid receptor antagonist with standard antihypertensive treatment in adults with low-renin essential hypertension.
A total of 128 eligible participants will be enrolled and randomly assigned in a 1:1 ratio to either an intervention group or a control group.
In the intervention group, participants will receive an eplerenone-based treatment strategy, starting with eplerenone 50 mg once daily. The dose may be gradually increased to 50 mg twice daily, and additional antihypertensive medications may be added according to blood pressure response and treatment tolerability.
In the control group, participants will receive standard antihypertensive treatment based on current clinical guidelines and routine practice. Medication doses may be gradually increased or treatment regimens adjusted according to blood pressure response and treatment tolerability.
In both groups, treatment will be adjusted to achieve an office seated blood pressure below 140/90 mmHg.
Participants will be followed for 24 weeks, with scheduled clinic visits at baseline and weeks 4, 12, and 24, supplemented by remote follow-up between visits.
The primary outcome is the change in mean daytime systolic blood pressure from baseline to week 12, assessed by 24-hour ambulatory blood pressure monitoring. Secondary outcomes include changes in office and ambulatory blood pressure, blood pressure control rates, treatment adjustments, time to blood pressure control, and antihypertensive medication burden assessed using defined daily doses.
Exploratory outcomes include changes in cardiac structure and function, urinary albumin-to-creatinine ratio, and circulating renin and aldosterone levels. Treatment safety will be evaluated throughout the study, with particular attention to hyperkalemia, changes in kidney function, symptomatic hypotension, and other adverse events.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive stepped antihypertensive treatment starting with eplerenone 50 mg orally once daily. Treatment will be intensified as needed by sequentially adding amlodipine 5 mg once daily, increasing eplerenone to 50 mg twice daily, increasing amlodipine to 5 mg twice daily, adding hydrochlorothiazide 12.5 mg once daily, adding doxazosin 4 mg once daily, and increasing hydrochlorothiazide to 25 mg once daily. Participants taking two antihypertensive drugs before washout will generally start with eplerenone plus amlodipine. Treatment adjustments will depend on blood pressure, tolerability, and safety assessments, with a target seated office blood pressure below 140/90 mmHg. Treatment will continue for 24 weeks.
Drug: Eplerenone
Participants will receive stepped antihypertensive treatment starting with telmisartan 40 mg orally once daily. Treatment will be intensified as needed by sequentially adding amlodipine 5 mg once daily, increasing telmisartan to 80 mg once daily, increasing amlodipine to 5 mg twice daily, adding hydrochlorothiazide 12.5 mg once daily, adding doxazosin 4 mg once daily, and increasing hydrochlorothiazide to 25 mg once daily. Participants taking two antihypertensive drugs before washout will generally start with telmisartan plus amlodipine. Treatment adjustments will depend on blood pressure, tolerability, and safety assessments, with a target seated office blood pressure below 140/90 mmHg. Treatment will continue for 24 weeks.
Drug: Telmisartan
Eplerenone will be administered orally at 50 mg once daily as the initial treatment in the experimental arm. The dose may be increased to 50 mg twice daily according to the prespecified treatment algorithm, blood pressure response, tolerability, serum potassium, and kidney function. Treatment will continue for 24 weeks, with dose reduction or interruption when clinically indicated.
Telmisartan will be administered orally at 40 mg once daily as the initial treatment in the active comparator arm. The dose may be increased to 80 mg once daily according to the prespecified treatment algorithm, blood pressure response, and tolerability. Treatment will continue for 24 weeks, with dose reduction or interruption when clinically indicated.
Change From Baseline in Mean Daytime Ambulatory Systolic Blood Pressure at Week 12
Change in mean daytime systolic blood pressure, measured in mmHg by 24-hour ambulatory blood pressure monitoring, from baseline to Week 12. Mean daytime systolic blood pressure is the average of all valid daytime systolic readings. A valid recording requires at least 70% of scheduled readings, including at least 20 daytime readings and 7 nighttime readings. Change is calculated as the Week 12 value minus the baseline value; a negative value indicates a reduction in blood pressure.
Time frame: Baseline and Week 12
Change From Baseline in Office Systolic Blood Pressure
Change in seated office systolic blood pressure, measured in mmHg, from baseline to each assessment. Measurements are obtained after at least 5 minutes of seated rest using a standardized upper-arm blood pressure monitor.
Time frame: Baseline, Week 12, and Week 24
Change From Baseline in Office Diastolic Blood Pressure
Change in seated office diastolic blood pressure, measured in mmHg, from baseline to each assessment. Measurements are obtained after at least 5 minutes of seated rest using a standardized upper-arm blood pressure monitor.
Time frame: Baseline, Week 12, and Week 24
Percentage of Participants Achieving Office Blood Pressure Control
Percentage of participants with seated office systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg at each assessment.
Time frame: Week 12 and Week 24
Percentage of Participants Achieving an Office Blood Pressure Response
Percentage of participants with a reduction from baseline in office systolic blood pressure of at least 10 mmHg, a reduction in office diastolic blood pressure of at least 5 mmHg, or achievement of office blood pressure below 140/90 mmHg.
Time frame: Baseline, Week 12, and Week 24
Number of Antihypertensive Treatment Adjustments
Cumulative number of antihypertensive treatment adjustments per participant, including dose increases, addition of a drug, and discontinuation of a drug.
Time frame: From randomization through Week 24
Time to First Documented Office Blood Pressure Control
Time, measured in weeks from randomization, to the first study visit at which seated office systolic blood pressure is below 140 mmHg and diastolic blood pressure is below 90 mmHg.
Time frame: From randomization through Week 24
Mean 24-Hour Ambulatory Systolic Blood Pressure
Mean systolic blood pressure, measured in mmHg, calculated from all valid readings during 24-hour ambulatory blood pressure monitoring at each assessment.
Time frame: Week 12 and Week 24
Mean 24-Hour Ambulatory Diastolic Blood Pressure
Mean diastolic blood pressure, measured in mmHg, calculated from all valid readings during 24-hour ambulatory blood pressure monitoring at each assessment.
Time frame: Week 12 and Week 24
Mean Nighttime Ambulatory Systolic Blood Pressure
Mean systolic blood pressure, measured in mmHg, calculated from all valid nighttime readings during ambulatory blood pressure monitoring at each assessment.
Time frame: Week 12 and Week 24
Mean Nighttime Ambulatory Diastolic Blood Pressure
Mean diastolic blood pressure, measured in mmHg, calculated from all valid nighttime readings during ambulatory blood pressure monitoring at each assessment.
Time frame: Week 12 and Week 24
Mean Daytime Ambulatory Diastolic Blood Pressure
Mean diastolic blood pressure, measured in mmHg, calculated from all valid daytime readings during ambulatory blood pressure monitoring at each assessment.
Time frame: Week 12 and Week 24
Antihypertensive Medication Burden at Achievement of Target Office Blood Pressure
Total antihypertensive medication burden required to achieve office blood pressure below 140/90 mmHg, expressed in World Health Organization defined daily dose equivalents. For each drug, the prescribed daily dose is divided by its defined daily dose, and the resulting values are summed across drugs.
Time frame: At achievement of target office blood pressure during the 24-week treatment period
Change From Baseline in Left Ventricular Mass Index
Change in echocardiographically measured left ventricular mass indexed to body surface area, expressed in g/m².
Time frame: Baseline and Week 24
Change From Baseline in Left Atrial Volume Index
Change in left atrial volume indexed to body surface area, measured by echocardiography and expressed in mL/m²
Time frame: Baseline and Week 24
Change From Baseline in Urinary Albumin-to-Creatinine Ratio
Change in urinary albumin-to-creatinine ratio, calculated by dividing urinary albumin concentration by urinary creatinine concentration
Time frame: Baseline and Week 24
Change From Baseline in Plasma Aldosterone Concentration
Change in plasma aldosterone concentration, measured using a standardized chemiluminescent immunoassay.
Time frame: Baseline and Week 24
Change From Baseline in Direct Renin Concentration
Change in direct renin concentration, expressed in mU/L and measured using the DiaSorin LIAISON chemiluminescent immunoassay
Time frame: Baseline and Week 24
Change From Baseline in Aldosterone-to-Renin Ratio
Change in the ratio of plasma aldosterone concentration to direct renin concentration
Time frame: Baseline and Week 24
Plan to share: Undecided — The plan for sharing de-identified individual participant data has not yet been determined. The decision will consider participant consent, ethics committee requirements, institutional policies, and applicable data protection regulations. This statement will be updated once a decision has been made.
Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.
Of 126 non-industry phase 4 interventional studies under Hypertension, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 54. This study's planned 12 months is below that.
Counting every sponsor, half of 161 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Eplerenone
China National Center for Cardiovascular Diseases →