Clinical trial NCT05030545: Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study
Official title: Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Primary Aldosteronism
Hypertension
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Change in myocardial flow reserve (MFR, unitless ratio)
timeFrame: 6 months
Secondary outcomes:
measure: Change in peak-stress myocardial blood flow (ml/min/g)
timeFrame: 6 months
measure: Change in Global Longitudinal Strain (%)
timeFrame: 6 months
measure: Change in LV Mass Index (g/m2 of body surface area)
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References: