Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy

Study Overview
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Brief Summary
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The purpose of this study is to determine whether taking losartan helps people with hypertrophic nonobstructive cardiomyopathy feel better by decreasing the amount of heart muscle thickening and/or the amount of heart muscle scarring.

Detailed Description
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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.

Official Title
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Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy

Conditions
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Hypertrophic Cardiomyopathy

Intervention / Treatment
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* Drug: losartan
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: losartan<br>Losartan 50 mg b.i.d. | Drug: losartan<br>* Losartan 50 mg b.i.d<br>* Other names: Cozaar;|
| Placebo Comparator: placebo<br>Placebo b.i.d. | Drug: placebo<br>* Placebo b.i.d.<br>* Other names: Placebo tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change From Baseline in Extent of Left Ventricular Fibrosis at 1 Year as Assessed by Magnetic Resonance Imaging. |  | Baseline and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change From Baseline in Left Ventricular Mass at 1 Year as Assessed by Magnetic Resonance Imaging. |  | Baseline and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertrophic nonobstructive cardiomyopathy