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Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01150461
First Posted: June 25, 2010
Last Update Posted: September 5, 2013
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.
Information provided by (Responsible Party):
Michael A. Fifer, MD, Massachusetts General Hospital
June 22, 2010
June 25, 2010
May 2, 2013
September 5, 2013
September 5, 2013
February 2007
July 2010   (Final data collection date for primary outcome measure)
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 ]
Extent of left ventricular myocardial fibrosis as assessed by magnetic resonance imaging. [ Time Frame: One Year ]
Complete list of historical versions of study NCT01150461 on ClinicalTrials.gov Archive Site
Percentage Change From Baseline in Left Ventricular Mass at 1 Year as Assessed by Magnetic Resonance Imaging. [ Time Frame: Baseline and 1 year ]
Left ventricular mass as assessed by magnetic resonance imaging. [ Time Frame: 1 year ]
Not Provided
Not Provided
 
Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy
Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Hypertrophic Cardiomyopathy
  • 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
  • Experimental: losartan
    Losartan 50 mg b.i.d.
    Intervention: Drug: losartan
  • Placebo Comparator: placebo
    Placebo b.i.d.
    Intervention: Drug: placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2010
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01150461
2006P002232/7
No
Not Provided
Not Provided
Michael A. Fifer, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Michael A Fifer, MD Massachusetts General Hospital
Massachusetts General Hospital
September 2013

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