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New treatment option for Hypertension
Official title Mineralocorticoid Receptor, Coronary Microvascular Function, and Cardiac Efficiency in Hypertension
ClinicalTrials.gov ID: NCT05593055
What this study is testing
What is Eplerenone?
Eplerenone is an investigational medicine, given as an once-daily, being studied as a potential treatment for hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The investigators' goal is to show that in hypertensive men and women with left ventricular hypertrophy (LVH) treatment with a mineralocorticoid receptor (MR) antagonist, versus a thiazide-like diuretic, will improve coronary microvascular function and cardiac efficiency, which will associate with improvements in LV structure and function. The investigators will achieve this through a randomized, controlled, basic experimental study involving humans (BESH).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- History of hypertension
- Seated systolic BP \< 180 mmHg and diastolic \< 110 mmHg if on antihypertensives
- Seated systolic BP 141-200 mmHg and/or diastolic BP 90-114 mmHg if not on antihypertensives
- LVH by echocardiogram
- For men: interventricular septum thickness ≥ 12mm
You likely can't join if
- Use of MR antagonist (eplerenone, spironolactone, or finerenone) or amiloride (amiloride inhibits ENaC, which is a key mediator of MR's actions)...
- Orthostatic hypotension
- Major medical illness, including uncontrolled diabetes mellitus (Hemoglobin A1c \>7.5)
- LV ejection fraction \< 40%
- New York Heart Association class III to IV congestive heart failure or unstable angina
- A history in the prior 6 months of Q-wave myocardial infarction, stroke, transient ischemic attack, percutaneous transluminal coronary angioplasty...
See the full eligibility criteria
- History of hypertension
- Seated systolic BP \< 180 mmHg and diastolic \< 110 mmHg if on antihypertensives
- Seated systolic BP 141-200 mmHg and/or diastolic BP 90-114 mmHg if not on antihypertensives
- LVH by echocardiogram
- For men: interventricular septum thickness ≥ 12mm
- For women: interventricular septum thickness ≥ 11mm
- We will also allow inclusion of people with treated hypothyroidism, pre-diabetes and diabetes controlled by diet, exercise, and/or metformin.
- Use of MR antagonist (eplerenone, spironolactone, or finerenone) or amiloride (amiloride inhibits ENaC, which is a key mediator of MR's actions) within the past year
- Orthostatic hypotension
- Major medical illness, including uncontrolled diabetes mellitus (Hemoglobin A1c \>7.5)
- LV ejection fraction \< 40%
- New York Heart Association class III to IV congestive heart failure or unstable angina
- A history in the prior 6 months of Q-wave myocardial infarction, stroke, transient ischemic attack, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft
- History of secondary hypertension
- Known genetic cardiomyopathy
- Renal disease (seum creatinine \>1.5 mg/dL for men and \>1.3 mg/dL for women)
- Hepatic disease
- Bronchospastic lung disease
- Alcohol or substance abuse
- Hormone replacement therapy
- Abnormal values for electrolytes, liver enzymes or TSH
- Pregnancy or lactation
- All individuals \ 75 years will be excluded due to safety concerns of administering an angiotensin-II infusion in these patient groups.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.