Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study
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|ClinicalTrials.gov Identifier: NCT05030545|
Recruitment Status : Not yet recruiting
First Posted : September 1, 2021
Last Update Posted : September 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Primary Aldosteronism Hypertension||Drug: Eplerenone||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study|
|Estimated Study Start Date :||October 2021|
|Estimated Primary Completion Date :||September 2026|
|Estimated Study Completion Date :||September 2026|
Experimental: Eplerenone Treatment
Eplerenone (50-100mg daily, as tolerated by blood pressure and potassium) for 6 months
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.
- Change in myocardial flow reserve (MFR, unitless ratio) [ Time Frame: 6 months ]The primary outcome is to evaluate the change in MFR, as measured by PET, pre- vs post-6 months of eplerenone therapy
- Change in peak-stress myocardial blood flow (ml/min/g) [ Time Frame: 6 months ]Peak stress myocardial blood flow is measured by PET after vasodilator-induced maximal hyperemia, before and after 6 months of eplerenone treatment
- Change in Global Longitudinal Strain (%) [ Time Frame: 6 months ]Global Longitudinal Strain is measured by echocardiography before and after 6 months of eplerenone treatment
- Change in LV Mass Index (g/m2 of body surface area) [ Time Frame: 6 months ]LV Mass Index is measured by echocardiography before and after 6 months of eplerenone treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05030545
|Contact: Jenifer M Brown, MDfirstname.lastname@example.org|