Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Aug 26, 2021

Keywords

ClinConnect Summary

The clinical trial titled "Cardiovascular Manifestations of MR Activation in Primary Aldosteronism" is investigating how a hormone called aldosterone affects the heart, particularly in patients with a condition known as primary aldosteronism (PA), which often leads to high blood pressure. The study aims to see if a medication that blocks aldosterone can help improve heart function in people who produce too much of this hormone. Participants will be closely monitored to understand the potential benefits of this treatment on their heart health.

To be eligible for the trial, you must be an adult between the ages of 18 and 85 and have high blood pressure that is being treated with at least one medication. There are two groups in the study: one for those who have been diagnosed with primary aldosteronism but have not yet started treatment with specific medications, and another for those with undiagnosed primary aldosteronism who have had recent heart tests. Participants can expect to undergo some medical imaging and assessments throughout the study to evaluate heart function. It's important to note that there are certain health conditions and medication allergies that may exclude someone from participating, so interested individuals should discuss their eligibility with their healthcare provider.

Gender

ALL

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.