No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Brigham and Women's Hospital · Other
Who this trial is looking for
This trial is looking for adults with high blood pressure caused by excess aldosterone. Participants will take a medication that blocks aldosterone to see if it improves heart function.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 85 years old.
I can give informed consent and follow study rules.
I can fit safely in the PET/CT scanner.
I have high blood pressure treated with medication.
I have a confirmed diagnosis of primary aldosteronism.
You may not be able to join if
I have had a heart attack or heart surgery.
I am allergic to eplerenone or spironolactone.
I am currently pregnant or breastfeeding.
My kidney function is very low or potassium levels are high.
I plan to have adrenal gland surgery in the next six months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 whethe…
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.
Trial Locations
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City
State
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Status
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)
* Hypert…
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.
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