Effect of Aldosterone on Energy Starvation in Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Myocardial Perfusion Index Reserve (MPRI) by Magnetic Resonance Imaging at 6 Months
研究概览
简要总结
We plan to study the concept of "energy starvation" in heart failure by evaluation of patients with nonischemic dilated cardiomyopathy (NIDCM) (heart failure with reduced heart pump function due to causes other than heart attack). We will use a combination of positron emission tomography and magnetic resonance imaging to study metabolism, anatomy, function, blood flow and efficiency, before and after 6 months' treatment with the drug spironolactone which blocks the deleterious effects of the hormone aldosterone on the myocardium (heart muscle).
详细描述
Preliminary results showed reduced subendocardial myocardial perfusion reserve in NIDCM compared to normal subjects, and that the degree of impaired perfusion reserve was related to the oxidative metabolic rate as measured by positron emission tomography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Nonischemic dilated cardiomyopathy
- •Left ventricular ejection fraction 35% or less
- •Stable heart failure symptoms
- •Able to undergo both positron emission tomography and magnetic resonance imaging with gadolinium
- •Able to tolerate treatment with spironolactone
排除标准
- •Serum potassium >5.0
- •Serum creatinine >2.5
- •Contraindications to magnetic resonance imaging such as internal cardioverter-defibrillator.
研究组 & 干预措施
Results with spironolactone
patients with heart failure due to nonischemic dilated cardiomyopathy will be studied by 11C acetate positron emission tomography and magnetic resonance imaging using vasodilator and gadolinium to judge myocardial blood flow, before and after 6 months' treatment with spironolactone.
干预措施: spironolactone (Drug)
结局指标
主要结局
Myocardial Perfusion Index Reserve (MPRI) by Magnetic Resonance Imaging at 6 Months
时间窗: 6 months
MPRI =calculated myocardial perfusion reserve index based on Gadolinium accretion into myocardium. MPRI was calculated as the ratio of stress/rest relative perfusion upslope, corrected for LV cavity upslope.
Change in Myocardial Fibrosis (T1 Time) by Magnetic Resonance Imaging
时间窗: baseline and 6 months
T1=left ventricular relaxation rate on magnetic resonance imaging, which is correlated with interstitial fibrosis.
Left Ventricular Work-metabolic Index (WMI) at Baseline
时间窗: baseline
WMI=\[left ventricular stroke work/decay rate of 11C-acetate\]
Myocardial Perfusion Reserve Index (MPRI) by Magnetic Resonance Imaging at Baseline
时间窗: baseline
MPRI =calculated myocardial perfusion reserve index based on Gadolinium accretion into myocardium. MPRI was calculated as the ratio of stress/rest relative perfusion upslope, corrected for LV cavity upslope.
Left Ventricular Work-metabolic Index (WMI) at 6 Months
时间窗: 6 months
WMI=\[left ventricular stroke work/decay rate of 11C-acetate\]
次要结局
- Minnesota Living With Heart Failure Questionnaire,at Baseline(baseline)
- 6 Minute Walk Test (6MWT) at Baseline(baseline)
- 6 Minute Walk Test (6MWT) at 6 Months(6 months)
- Minnesota Living With Heart Failure Questionnaire.at 6 Months(6 months)
研究者
Marvin W. Kronenberg, M.D.
Professor of Medicine and Radiology
Vanderbilt University