Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Hypertrophic Cardiomyopathy

Treatments: Drug: losartan; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01150461

2006P002232/7

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

losartan

Experimental group

Description:

Losartan 50 mg b.i.d.

Treatment:

Drug: losartan

placebo

Placebo Comparator group

Description:

Placebo b.i.d.

Treatment:

Drug: placebo