Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy
研究概览
详细说明
Hypertrophic cardiomyopathy (HCM) is characterized by idiopathic cardiac hypertrophy, heart failure, ischemia even in the absence of epicardial coronary artery disease, and arrhythmias. The pathological features of HCM include hypertrophy and disarray, interstitial fibrosis, and increased arteriolar wall thickness. Hypertrophy and fibrosis are major determinants of morbidity and mortality in hypertrophic cardiomyopathy. Some investigators have demonstrated that interstitial fibrosis and hypertrophy occur secondarily, in response to trophic and mitotic factors in the heart. Therefore, blocking trophic factors may attenuate or potentially reverse hypertrophy and fibrosis in HCM.
Angiotensin II has trophic and profibrotic effects on the heart, and blockade of angiotensin II type I receptors has been shown to attenuate myocardial hypertrophy and fibrosis in acquired cardiac disease in humans and animal models.
We hypothesize that treatment with the selective angiotensin II type receptor antagonist, losartan, will decrease both hypertrophy and fibrosis, improve diastolic function, reduce symptoms, and improve functional status in patients with HCM.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
-
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients with hypertrophic cardiomyopathy
- Left ventricular outflow tract (LVOT) gradient less than 30 mm Hg at rest
- Age 18 years or older
Exclusion Criteria:
- Contraindication to losartan
- Already taking losartan
- Contraindication to MRI
- Hemodynamic instability
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:losartan
Losartan 50 mg b.i.d.
|
Losartan 50 mg b.i.d
其他名称:
|
|
安慰剂比较:placebo
Placebo b.i.d.
|
Placebo b.i.d.
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Percentage Change From Baseline in Extent of Left Ventricular Fibrosis at 1 Year as Assessed by Magnetic Resonance Imaging.
大体时间:Baseline and 1 year
|
Baseline and 1 year
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Percentage Change From Baseline in Left Ventricular Mass at 1 Year as Assessed by Magnetic Resonance Imaging.
大体时间:Baseline and 1 year
|
Baseline and 1 year
|
合作者和调查者
调查人员
- 首席研究员:Michael A Fifer, MD、Massachusetts General Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2006P002232/7
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