Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study
Recruiting · NCT05030545 · Interventional (participants receive a specific treatment) · Lead sponsor: Brigham and Women's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Brigham and Women's Hospital - Boston, Massachusetts, United States