Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Michael A. Fifer, MD, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT01150461

First received: June 22, 2010

Last updated: June 7, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 22, 2010

Last Updated Date

June 7, 2012

Start Date ^ICMJE

February 2007

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Extent of left ventricular myocardial fibrosis as assessed by magnetic resonance imaging. [ Time Frame: One Year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01150461 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Left ventricular mass as assessed by magnetic resonance imaging. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy

Official Title ^ICMJE

Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Hypertrophic Cardiomyopathy

Intervention ^ICMJE

Drug: losartan
Losartan 50 mg b.i.d
Other Names:
- Angiotensin II receptor antagonist
- Cozaar
Drug: placebo
Placebo b.i.d.

Other Name: Placebo tablet

Study Arm (s)

Experimental: losartan
Losartan 50 mg b.i.d.

Intervention: Drug: losartan
Placebo Comparator: placebo
Placebo b.i.d.

Intervention: Drug: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2010

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01150461

Other Study ID Numbers ^ICMJE

2006P002232/7

Has Data Monitoring Committee

Responsible Party

Michael A. Fifer, MD, Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Michael A Fifer, MD

Massachusetts General Hospital

Information Provided By

Massachusetts General Hospital

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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