NCT05030545 · Brigham and Women's Hospital
Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study
What this study 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.
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 7, 2025 · Source of record for eligibility and locations