No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Basic Science
Participants needed
75 (estimated)
Sponsor
Brigham and Women's Hospital · Other
Who this trial is looking for
This trial is looking for people with high blood pressure who also have changes in their heart structure. Participants will receive either a mineralocorticoid receptor blocker or a water pill to see which one helps improve heart blood flow and function better.
Are You a Good Fit for This Trial?
Must not be takingEplerenoneSpironolactoneFinerenoneAmiloride
You may be able to join if
I have high blood pressure.
I have left ventricular hypertrophy (LVH) confirmed by an echocardiogram.
I am being treated for hypothyroidism.
I have pre-diabetes or diabetes managed by diet, exercise, or metformin.
You may not be able to join if
I have had a heart attack, stroke, or similar serious heart issue in the past 6 months.
I have uncontrolled diabetes with a Hemoglobin A1c greater than 7.5.
I have kidney disease.
I have a heart function that is very low (ejection fraction less than 40%).
I have severe heart failure or unstable angina.
I have a history of secondary hypertension or known genetic heart disease.
I am pregnant or breastfeeding.
I am under 18 or over 75 years old.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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, …
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).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. History of hypertension
1. Seated systolic BP \< 180 mmHg and diastolic \< 110 mmHg if on antihypertensives
2. Seated systolic BP 141-200 mmHg and/or diastolic BP 90-114 mmHg if not on antihypertensives
2. LVH by echocardiogram
1. For men: interventricular septum t…
Inclusion Criteria:
1. History of hypertension
1. Seated systolic BP \< 180 mmHg and diastolic \< 110 mmHg if on antihypertensives
2. Seated systolic BP 141-200 mmHg and/or diastolic BP 90-114 mmHg if not on antihypertensives
2. LVH by echocardiogram
1. For men: interventricular septum thickness ≥ 12mm
2. For women: interventricular septum thickness ≥ 11mm
3. We will also allow inclusion of people with treated hypothyroidism, pre-diabetes and diabetes controlled by diet, exercise, and/or metformin.
Exclusion Criteria:
* 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 \<18 and \>75 years will be excluded due to safety concerns of administering an angiotensin-II infusion in these patient groups.
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