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Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01150461
Recruitment Status : Completed
First Posted : June 25, 2010
Results First Posted : September 5, 2013
Last Update Posted : September 5, 2013
Sponsor:
Information provided by (Responsible Party):
Michael A. Fifer, MD, Massachusetts General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertrophic Cardiomyopathy Drug: losartan Drug: placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy
Study Start Date : February 2007
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arms and Interventions
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Arm Intervention/treatment
Experimental: losartan
Losartan 50 mg b.i.d.
 Drug: losartan
Losartan 50 mg b.i.d
Other Names:
  • Angiotensin II receptor antagonist
  • Cozaar
Placebo Comparator: placebo
Placebo b.i.d.
 Drug: placebo
Placebo b.i.d.
Other Name: Placebo tablet


Outcome Measures
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Primary Outcome Measures :
  1. Percentage Change From Baseline in Extent of Left Ventricular Fibrosis at 1 Year as Assessed by Magnetic Resonance Imaging. [ Time Frame: Baseline and 1 year ]

Secondary Outcome Measures :
  1. Percentage Change From Baseline in Left Ventricular Mass at 1 Year as Assessed by Magnetic Resonance Imaging. [ Time Frame: Baseline and 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150461


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Michael A Fifer, MD Massachusetts General Hospital
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Michael A. Fifer, MD, Director, Hypertrophic Cardiomyopathy Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01150461    
Other Study ID Numbers: 2006P002232/7
First Posted: June 25, 2010    Key Record Dates
Results First Posted: September 5, 2013
Last Update Posted: September 5, 2013
Last Verified: September 2013
Keywords provided by Michael A. Fifer, MD, Massachusetts General Hospital:
Hypertrophic nonobstructive cardiomyopathy
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
 Losartan
Angiotensin II
Angiotensin Receptor Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents