RECRUITING

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

Conditions

Hypertension Left Ventricular Hypertrophy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2023-08-25

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05593055

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: LV mass index \> 134 g/m2 2. For women: LV mass index \> 110 g/m2 3. 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 \<18 and \>70 years will be excluded due to safety concerns of administering an angiotensin-II infusion in these patient groups.

Inclusion Criteria

Exclusion 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: LV mass index \> 134 g/m2
2. For women: LV mass index \> 110 g/m2
3. 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 \<18 and \>70 years will be excluded due to safety concerns of administering an angiotensin-II infusion in these patient groups.

Contacts and Locations

Study Contact

Gail K Adler, MD, PhD

CONTACT

781-223-2686

gadler@bwh.harvard.edu

Principal Investigator

Gail K Adler, MD, PhD

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Gail K Adler, MD, PhD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-25

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2023-08-25

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

Hypertension
Left Ventricular Hypertrophy