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Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy

NCT ID: NCT01150461

Last Updated: 2013-09-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2010-07-31

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.

Conditions

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Hypertrophic Cardiomyopathy

Keywords

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Hypertrophic nonobstructive cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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losartan

Losartan 50 mg b.i.d.

Group Type EXPERIMENTAL

losartan

Intervention Type DRUG

Losartan 50 mg b.i.d

placebo

Placebo b.i.d.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo b.i.d.

Interventions

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losartan

Losartan 50 mg b.i.d

Intervention Type DRUG

placebo

Placebo b.i.d.

Intervention Type DRUG

Other Intervention Names

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Angiotensin II receptor antagonist Cozaar Placebo tablet

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Michael A. Fifer, MD

Director, Hypertrophic Cardiomyopathy Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael A Fifer, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Shimada YJ, Passeri JJ, Baggish AL, O'Callaghan C, Lowry PA, Yannekis G, Abbara S, Ghoshhajra BB, Rothman RD, Ho CY, Januzzi JL, Seidman CE, Fifer MA. Effects of losartan on left ventricular hypertrophy and fibrosis in patients with nonobstructive hypertrophic cardiomyopathy. JACC Heart Fail. 2013 Dec;1(6):480-7. doi: 10.1016/j.jchf.2013.09.001. Epub 2013 Oct 24.

Reference Type DERIVED
PMID: 24621999 (View on PubMed)

Related Links

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http://www.mgh.harvard.edu/heartcenter/services/treatmentprograms.aspx?id=1009

The Hypertrophic Cardiomyopathy Program at the Massachusetts General Hospital Heart Center

Other Identifiers

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2006P002232/7

Identifier Type: -

Identifier Source: org_study_id