NCT05593055RecruitingPhase 4
Mineralocorticoid Receptor, Coronary Microvascular Function, and Cardiac Efficiency in Hypertension
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 20 Oct 2022
- Start date
- 25 Aug 2023
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- High blood pressure
- NCT number
- NCT05593055
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 75
- From 25 Aug 2023 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Hormone replacement therapy
Other illness
- New York Heart Association class III to IV congestive heart failure or unstable angina
- History of secondary hypertension
- Hepatic disease
- Bronchospastic lung disease
Lab values
- Major medical illness, including uncontrolled diabetes mellitus (Hemoglobin A1c \>7.5)
- LV ejection fraction \< 40%
- Renal disease (seum creatinine \>1.5 mg/dL for men and \>1.3 mg/dL for women)
Age
- All individuals \<18 and \>75 years will be excluded due to safety concerns of administering an angiotensin-II infusion in these patient groups.
Other
- 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
- Known genetic cardiomyopathy
- Alcohol or substance abuse
- Abnormal values for electrolytes, liver enzymes or TSH
- Pregnancy or lactation
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.