Effect of Aldosterone on Energy Starvation in Heart Failure
2019年5月30日 更新者：Marvin W. Kronenberg, M.D.、Vanderbilt University
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).
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
16
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Tennessee
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Nashville、Tennessee、美国、37232
- Vanderbilt Heart and Vascular Institute
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Serum potassium >5.0
- Serum creatinine >2.5
- Contraindications to magnetic resonance imaging such as internal cardioverter-defibrillator.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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.
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spironolactone 50 mg daily for 6 months
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Left Ventricular Work-metabolic Index (WMI) at Baseline
大体时间：baseline
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WMI=[left ventricular stroke work/decay rate of 11C-acetate]
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baseline
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Left Ventricular Work-metabolic Index (WMI) at 6 Months
大体时间：6 months
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WMI=[left ventricular stroke work/decay rate of 11C-acetate]
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6 months
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Myocardial Perfusion Reserve Index (MPRI) by Magnetic Resonance Imaging at Baseline
大体时间：baseline
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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.
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baseline
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Myocardial Perfusion Index Reserve (MPRI) by Magnetic Resonance Imaging at 6 Months
大体时间：6 months
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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.
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6 months
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Change in Myocardial Fibrosis (T1 Time) by Magnetic Resonance Imaging
大体时间：baseline and 6 months
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T1=left ventricular relaxation rate on magnetic resonance imaging, which is correlated with interstitial fibrosis.
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baseline and 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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6 Minute Walk Test (6MWT) at Baseline
大体时间：baseline
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6MWT assesses distance walked over 6 minutes
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baseline
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6 Minute Walk Test (6MWT) at 6 Months
大体时间：6 months
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6MWT assesses distance walked over 6 minutes
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6 months
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Minnesota Living With Heart Failure Questionnaire,at Baseline
大体时间：baseline
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The questionnaire is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life.
Each question is scored from 0 (none or not applicable) to 5 (very much).
Total scores range from 0-105.
Low scores indicate less adverse impact, while higher scores reflect more adverse impact of heart failure.
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baseline
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Minnesota Living With Heart Failure Questionnaire.at 6 Months
大体时间：6 months
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The questionnaire is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life.
Each question is scored from 0 (none or not applicable) to 5 (very much).
Total scores range from 0-105.
Low scores indicate less adverse impact, while higher scores reflect more adverse impact of heart failure.
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6 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Marvin W Kronenberg, MD、Vanderbilt University School of Medicine
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Lawson MA, Hansen DE, Gupta DK, Bell SP, Adkisson DW, Mallugari RR, Sawyer DB, Ooi H, Kronenberg MW. Modification of ventriculo-arterial coupling by spironolactone in nonischemic dilated cardiomyopathy. ESC Heart Fail. 2021 Apr;8(2):1156-1166. doi: 10.1002/ehf2.13161. Epub 2021 Jan 5.
- Bradham WS, Bell SP, Huang S, Harrell FE Jr, Adkisson DW, Lawson MA, Sawyer DB, Ooi H, Kronenberg MW. Timing of Left Ventricular Remodeling in Nonischemic Dilated Cardiomyopathy. Am J Med Sci. 2018 Sep;356(3):262-267. doi: 10.1016/j.amjms.2018.06.003. Epub 2018 Jun 8.
- Lawson MA, Bell SP, Adkisson DW, Wang L, Ooi H, Sawyer DB, Kronenberg MW. High reproducibility of adenosine stress cardiac MR myocardial perfusion imaging in patients with non-ischaemic dilated cardiomyopathy. BMJ Open. 2014 Dec 16;4(12):e005984. doi: 10.1136/bmjopen-2014-005984.
- Bell SP, Adkisson DW, Lawson MA, Wang L, Ooi H, Sawyer DB, Kronenberg MW. Antifailure therapy including spironolactone improves left ventricular energy supply-demand relations in nonischemic dilated cardiomyopathy. J Am Heart Assoc. 2014 Aug 27;3(4):e000883. doi: 10.1161/JAHA.114.000883.
- Bell SP, Adkisson DW, Ooi H, Sawyer DB, Lawson MA, Kronenberg MW. Impairment of subendocardial perfusion reserve and oxidative metabolism in nonischemic dilated cardiomyopathy. J Card Fail. 2013 Dec;19(12):802-10. doi: 10.1016/j.cardfail.2013.10.010. Epub 2013 Oct 29.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年12月1日
初级完成 (实际的)
2012年7月1日
研究完成 (实际的)
2012年7月1日
研究注册日期
首次提交
2007年12月13日
首先提交符合 QC 标准的
2007年12月14日
首次发布 (估计)
2007年12月17日
研究记录更新
最后更新发布 (实际的)
2019年6月18日
上次提交的符合 QC 标准的更新
2019年5月30日
最后验证
2019年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
spironolactone的临床试验
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October 6 UniversityBeni-Suef University; National Heart Institute, Egypt招聘中