Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy
Primary Purpose
Hypertrophic Cardiomyopathy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
losartan
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypertrophic Cardiomyopathy focused on measuring Hypertrophic nonobstructive cardiomyopathy
Eligibility 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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
losartan
placebo
Arm Description
Losartan 50 mg b.i.d.
Placebo b.i.d.
Outcomes
Primary Outcome Measures
Percentage Change From Baseline in Extent of Left Ventricular Fibrosis at 1 Year as Assessed by Magnetic Resonance Imaging.
Secondary Outcome Measures
Percentage Change From Baseline in Left Ventricular Mass at 1 Year as Assessed by Magnetic Resonance Imaging.
Full Information
NCT ID
NCT01150461
First Posted
June 22, 2010
Last Updated
September 3, 2013
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01150461
Brief Title
Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy
Official Title
Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Cardiomyopathy
Keywords
Hypertrophic nonobstructive cardiomyopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
losartan
Arm Type
Experimental
Arm Description
Losartan 50 mg b.i.d.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo b.i.d.
Intervention Type
Drug
Intervention Name(s)
losartan
Other Intervention Name(s)
Angiotensin II receptor antagonist, Cozaar
Intervention Description
Losartan 50 mg b.i.d
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
Placebo tablet
Intervention Description
Placebo b.i.d.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Percentage Change From Baseline in Left Ventricular Mass at 1 Year as Assessed by Magnetic Resonance Imaging.
Time Frame
Baseline and 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Fifer, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24621999
Citation
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.
Results Reference
derived
Links:
URL
http://www.mgh.harvard.edu/heartcenter/services/treatmentprograms.aspx?id=1009
Description
The Hypertrophic Cardiomyopathy Program at the Massachusetts General Hospital Heart Center
Learn more about this trial
Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy
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