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Recruiting NCT05030545

Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study

Phase IV Interventional Primary Aldosteronism Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Eplerenone.
Who it may be relevant to
Registry conditions: Primary Aldosteronism, Hypertension. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This research study aims to learn more about the impact the hormone aldosterone on the heart. Primary aldosteronism is a condition where the body's adrenal glands make too much of the hormone aldosterone, which can cause high blood pressure and increase the risk of heart and kidney disease. Treatment with medications that block aldosterone can reduce that risk. This study is trying to learn whether treatment with a medication that blocks aldosterone can improve heart function in people who make too much aldosterone.

Detailed description

The study evaluates the impact of 6 months of treatment with the mineralocorticoid receptor blocking medication eplerenone on the heart's blood flow, using a cardiac PET stress test, and on the heart's structure and function by echocardiogram.

Participants with a confirmed diagnosis of primary aldosteronism will undergo echocardiogram and cardiac PET stress test before and after 6 months of eplerenone treatment.

Participants without a confirmed diagnosis of primary aldosteronism but with hypertension and a recent clinical PET test and echocardiogram will undergo testing to make the diagnosis of primary aldosteronism. Those who test positive will go on to treatment with eplerenone for 6 months, followed by a cardiac PET scan and echocardiogram.

Interventions

  • Drug Eplerenone
    After baseline cardiac imaging with PET and echocardiogram, participants will be treated with eplerenone for 6 months at a starting dose of 50mg daily and up to a maximally tolerated dose of 100mg daily, followed by repeat imaging with PET and echocardiogram.

Primary outcome measures

  • Change in myocardial flow reserve (MFR, unitless ratio) [Time frame: 6 months]
Secondary outcome measures (3)
  • Change in peak-stress myocardial blood flow (ml/min/g) [Time frame: 6 months]
  • Change in Global Longitudinal Strain (%) [Time frame: 6 months]
  • Change in LV Mass Index (g/m2 of body surface area) [Time frame: 6 months]

Eligibility criteria

Cohort A: Overt \& Diagnosed PA

Inclusion criteria

  • Adults aged 18-85
  • Able to provide informed consent and willing to comply with the study
  • Able to fit safely in PET/CT scanner (weight limit 500 pounds; diameter and circumference of PET/CT scanner are 70 cm and 220 cm, respectively)
  • Hypertension treated with at least one antihypertensive drug
  • Cohort A: Clinically confirmed diagnosis of PA not yet treated with mineralocorticoid receptor antagonists

Exclusion criteria

  • History of MI, CABG, known cardiomyopathy (EF <40%, hypertrophic cardiomyopathy, and/or amyloid), cardiac transplantation
  • Contraindication or allergy to eplerenone or spironolactone
  • Current pregnancy or breastfeeding
  • eGFR < 45 mL/min/1.73m2 or potassium > 5.1 on labs within the preceding 3 months
  • Cohort A: Planned adrenalectomy in the subsequent 6 months

Cohort B: Subclinical \& Undiagnosed PA

Inclusion criteria

  • Adults aged 18-85
  • Able to provide informed consent and willing to comply with the study
  • Able to fit safely in PET/CT scanner (weight limit 500 pounds; diameter and circumference of PET/CT scanner are 70 cm and 220 cm, respectively)
  • Hypertension treated with at least one antihypertensive drug
  • Cohort B: Clinically indicated cardiac PET perfusion scan within the preceding 3 months and echocardiogram within the preceding 6 months

Exclusion criteria

  • History of MI, CABG, known cardiomyopathy (EF <40%, hypertrophic cardiomyopathy, and/or amyloid), cardiac transplantation
  • Contraindication or allergy to eplerenone or spironolactone
  • Current pregnancy or breastfeeding
  • eGFR < 45 mL/min/1.73m2 or potassium > 5.1 on labs within the preceding 3 months
  • Cohort B: 10% or greater burden of ischemia on qualifying PET
  • Cohort B: Planned coronary angiogram/revascularization in the subsequent 6 months.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Brigham and Women's Hospital — Boston

Identifiers

NCT: NCT05030545 · 2021P002400

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗