Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy

Phase 2

Completed

• Conditions: Hypertrophic Cardiomyopathy
• Interventions: Drug: losartan; Drug: placebo

• Registration Number: NCT01150461
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2010-06-22
• Study First Submitted QC: 2010-06-24
• Study First Posted: 2010-06-25
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2013-05-02
• Status Verified: 2013-09
• Results First Submitted QC: 2013-09-03
• Last Update Submitted: 2013-09-03
• Results First Posted: 2013-09-05
• Last Update Posted: 2013-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
losartan	losartan	Losartan 50 mg b.i.d.
placebo	placebo	Placebo b.i.d.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Percentage Change From Baseline in Left Ventricular Mass at 1 Year as Assessed by Magnetic Resonance Imaging.	Baseline and 1 year

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States