Primary AldosteronismPhase 4NCT05030545
Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study
A Phase 4 study testing Eplerenone in people with Primary Aldosteronism and Hypertension, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Primary Aldosteronism, Hypertension
- What is being tested?
- Eplerenone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2022to 28 Feb 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Eva Abel, 617-525-3803
About this study
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.
Read the detailed description
The study evaluates the impact of 6 months of treatment with the mineralocorticoid receptor blocking medication eplerenone on the heart's blood flow, using a cardiac PET stress test, and on the heart's structure and function by echocardiogram.
Participants with a confirmed diagnosis of primary aldosteronism will undergo echocardiogram and cardiac PET stress test before and after 6 months of eplerenone treatment.
Participants without a confirmed diagnosis of primary aldosteronism but with hypertension and a recent clinical PET test and echocardiogram will undergo testing to make the diagnosis of primary aldosteronism. Those who test positive will go on to treatment with eplerenone for 6 months, followed by a cardiac PET scan and echocardiogram.
- Conditions
- Primary Aldosteronism, Hypertension
- Being tested
- Eplerenone
- Medical subject headings
- Hyperaldosteronism, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EplerenoneDrug
Also called Inspra, Mineralocorticoid Receptor Antagonist
After baseline cardiac imaging with PET and echocardiogram, participants will be treated with eplerenone for 6 months at a starting dose of 50mg daily and up to a maximally tolerated dose of 100mg daily, followed by repeat imaging with PET and echocardiogram.
| Study group | Role | What they receive |
|---|---|---|
| Eplerenone Treatment | Experimental | Eplerenone (50-100mg daily, as tolerated by blood pressure and potassium) for 6 months Receives: Drug: Eplerenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in myocardial flow reserve (MFR, unitless ratio)
The primary outcome is to evaluate the change in MFR, as measured by PET, pre- vs post-6 months of eplerenone therapy
Measured: 6 months
Secondary outcomes (3)
Change in peak-stress myocardial blood flow (ml/min/g)
Peak stress myocardial blood flow is measured by PET after vasodilator-induced maximal hyperemia, before and after 6 months of eplerenone treatment
Measured: 6 months
Change in Global Longitudinal Strain (%)
Global Longitudinal Strain is measured by echocardiography before and after 6 months of eplerenone treatment
Measured: 6 months
Change in LV Mass Index (g/m2 of body surface area)
LV Mass Index is measured by echocardiography before and after 6 months of eplerenone treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start15 Dec 2022
- Primary completion31 Oct 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenifer M. Brown, M.D., Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030545
- Sponsor's protocol ID
- 2021P002400
- Status last verified
- Oct 2026
- First submitted
- 26 Aug 2021
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No