Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy
Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertrophic Cardiomyopathy
Intervention: losartan (Drug); placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s): Michael A Fifer, MD, Principal Investigator, Affiliation: Massachusetts General Hospital
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.
Clinical Details
Official title: Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Percentage Change From Baseline in Extent of Left Ventricular Fibrosis at 1 Year as Assessed by Magnetic Resonance Imaging.
Secondary outcome: Percentage Change From Baseline in Left Ventricular Mass at 1 Year as Assessed by Magnetic Resonance Imaging.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information
The Hypertrophic Cardiomyopathy Program at the Massachusetts General Hospital Heart Center
Starting date: February 2007
Last updated: September 3, 2013
|