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Mineralocorticoid Receptor, Coronary Microvascular Function, and Cardiac Efficiency in Hypertension

StatusRecruiting
PhasePhase 4
Started2023-08-25
View on ClinicalTrials.gov ↗

Amendment history

2026-04-03
Study Status v6
Primary completion pushed: 2027-01-01 → 2027-04-01
2025-12-30
Study Status, Oversight, Contacts/Locations, IPDSharing v5
Primary completion date2026-09-01→2027-01-01
Completion date2026-12-31→2027-12-31
Study sitescontacts updated at 1 of 1 site
2024-12-11
Study Status, Oversight, Eligibility, Contacts/Locations, IPDSharing v4
Eligibility criteria+32 characters
[...] if not on antihypertensives LVH by echocardiogram For men: LVinterventricular massseptum indexthickness >≥ 134 g/m212mm For women: LVinterventricular massseptum indexthickness >≥ 110 g/m211mm We will also allow inclusion of people with treated hypothy [...] ymes or TSH Pregnancy or lactation All individuals <18 and >7075 years will be excluded due to safety concerns of administering an angiotensin-II infusion in these patient groups.
Study sitescontacts updated at 1 of 1 site
2023-11-15
Study Status, Eligibility v3
Primary completion date2027-04→2026-09-01
Completion date2028-04→2026-12-31
Start date2022-10-20→2023-08-25
2023-07-25
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-04→confirmed 2022-10-20
Study sites0→1
Eligibility criteria+274 characters
Inclusion Criteria: History of hypertension Seated systolic BP < 160180 mmHg and diastolic < 100110 mmHg if on antihypertensives Seated systolic BP 141-200 mmH [...] ndex > 110 g/m2 We will also allow inclusion of people with treated hypothyroidism, pre-diabetes and treateddiabetes hypothyroidismcontrolled by diet, exercise, and/or metformin. Exclusion Criteria: Use of MR antagonist (eplerenone, spiro [...] ar Orthostatic hypotension Major medical illness, including uncontrolled diabetes mellitus Documented coronary disease (priorHemoglobin revascularizationA1c and/or myocardial infarction>7.5) LV ejection [...] [...]
2022-10-26
Study Status, Sponsor/Collaborators, Study Description, Arms and Interventions v1
InterventionsChlorthalidone (Drug), Eplerenone (Drug)→Chlorthalidone (Drug), Eplerenone (Drug), Potassium (Drug)
Study description+75 characters
WeThe investigators are recruiting individuals with hypertension and LVH, as de [...] st) or chlorthalidone (thiazide-like diuretic) + potassium. WeThe investigators will use cardiac PET to quantify changes in coronary microv [...] graphy to assess changes in cardiac function and structure. WeThe investigators will define the impact of eplerenone as compared with chlor [...] icrovascular function and cardiac efficiency. Additionally, wethe investigators will determine whether improvements in coronary microvascul [...] rdial work over myocardial oxygen consumption and LV mass). WeThe investigators will also measure: 1) my [...]
2022-10-20
Original filing
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 Details
NCT Number NCT05593055
Lead Sponsor Brigham and Women's Hospital
Conditions Hypertension, Left Ventricular Hypertrophy
Enrollment 75 participants
Start Date 2023-08-25
Primary Completion 2027-04-01 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-06