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NCT05030545
Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study
Conditions: Primary Aldosteronism, Hypertension
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 40
Sponsor: Brigham and Women's Hospital
Location: Brigham and Women's Hospital Boston Massachusetts
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.
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 \ 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 \ 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.
Source: ClinicalTrials.gov (NCT05030545). StuddyBuddy aggregates publicly available trial information.