Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in myocardial flow reserve (MFR, unitless ratio)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Eplerenone Treatment
Eplerenone (50-100mg daily, as tolerated by blood pressure and potassium) for 6 months
干预措施: Eplerenone (Drug)
结局指标
主要结局
Change in myocardial flow reserve (MFR, unitless ratio)
时间窗: 6 months
The primary outcome is to evaluate the change in MFR, as measured by PET, pre- vs post-6 months of eplerenone therapy
次要结局
- Change in LV Mass Index (g/m2 of body surface area)(6 months)
- Change in peak-stress myocardial blood flow (ml/min/g)(6 months)
- Change in Global Longitudinal Strain (%)(6 months)
研究者
Jenifer M. Brown, M.D.
Instructor in Medicine
Brigham and Women's Hospital