Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study
Recruiting now · Phase 4
Conditions studied: Primary Aldosteronism, Hypertension
In brief
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.
Key facts
- Study ID
- NCT05030545
- Run by
- Brigham and Women's Hospital
- People needed
- 40
- Starts
- 2022-12-15
- Expected to finish
- 2027-02-28
- Last updated by the study team
- 2025-02-07
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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