NCT05030545RecruitingPhase 4
Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 26 Aug 2021
- Start date
- 15 Dec 2022
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- High blood pressure
- NCT number
- NCT05030545
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 40
- From 15 Dec 2022 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of MI, CABG, known cardiomyopathy (EF \<40%, hypertrophic cardiomyopathy, and/or amyloid), cardiac transplantation
- Contraindication or allergy to eplerenone or spironolactone
- History of MI, CABG, known cardiomyopathy (EF \<40%, hypertrophic cardiomyopathy, and/or amyloid), cardiac transplantation
- Contraindication or allergy to eplerenone or spironolactone
Lab values
- eGFR \< 45 mL/min/1.73m2 or potassium \> 5.1 on labs within the preceding 3 months
- eGFR \< 45 mL/min/1.73m2 or potassium \> 5.1 on labs within the preceding 3 months
Other
- Current pregnancy or breastfeeding
- Cohort A: Planned adrenalectomy in the subsequent 6 months
- Cohort B: Subclinical \& Undiagnosed PA
- Current pregnancy or breastfeeding
- Cohort B: 10% or greater burden of ischemia on qualifying PET
- Cohort B: Planned coronary angiogram/revascularization in the subsequent 6 months.
Who the study is looking for
- 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
- 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
Criteria the registry did not label
- Cohort A: Overt \& Diagnosed PA
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.