Impact of Aldosterone Blockade on Heart Function in Primary Aldosteronism
Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study
This study is testing if a medication that blocks a hormone called aldosterone can improve heart function in people with primary aldosteronism, which causes high blood pressure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05030545 on ClinicalTrials.gov |
What this trial studies
This pilot clinical study investigates how the hormone aldosterone affects heart function in patients with primary aldosteronism, a condition characterized by excessive aldosterone production leading to hypertension. Participants will receive treatment with eplerenone, a medication that blocks aldosterone, for six months. The study will assess changes in heart blood flow and structure using cardiac PET stress tests and echocardiograms before and after treatment. Both diagnosed and undiagnosed patients with primary aldosteronism will be included in the evaluation.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-85 with a confirmed diagnosis of primary aldosteronism or those with hypertension who may have undiagnosed primary aldosteronism.
Not a fit: Patients with a history of significant heart conditions, contraindications to eplerenone, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved heart function and reduced cardiovascular risks for patients with primary aldosteronism.
How similar studies have performed: Other studies have shown promising results with mineralocorticoid receptor antagonists in improving cardiovascular outcomes, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Jenifer M Brown, MD
- Email: jbrown35@bwh.harvard.edu
- Phone: 8573071990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.