NCT05030545 Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study
| NCT ID | NCT05030545 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Brigham and Women's Hospital |
| Condition | Primary Aldosteronism |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-12-15 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2022-12-15 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05030545 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Primary Aldosteronism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05030545 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05030545 currently recruiting?
Yes, NCT05030545 is actively recruiting participants. Contact the research team at jbrown35@bwh.harvard.edu for enrollment information.
Where is the NCT05030545 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05030545 clinical trial?
NCT05030545 is sponsored by Brigham and Women's Hospital. The trial plans to enroll 40 participants.