Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2007
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 22, 2010
CompletedFirst Posted
Study publicly available on registry
June 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedResults Posted
Study results publicly available
September 5, 2013
CompletedSeptember 5, 2013
September 1, 2013
3.4 years
June 22, 2010
May 2, 2013
September 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage Change From Baseline in Extent of Left Ventricular Fibrosis at 1 Year as Assessed by Magnetic Resonance Imaging.
Baseline and 1 year
Secondary Outcomes (1)
Percentage Change From Baseline in Left Ventricular Mass at 1 Year as Assessed by Magnetic Resonance Imaging.
Baseline and 1 year
Study Arms (2)
losartan
EXPERIMENTALLosartan 50 mg b.i.d.
placebo
PLACEBO COMPARATORPlacebo b.i.d.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with hypertrophic cardiomyopathy
- Left ventricular outflow tract (LVOT) gradient less than 30 mm Hg at rest
- Age 18 years or older
You may not qualify if:
- Contraindication to losartan
- Already taking losartan
- Contraindication to MRI
- Hemodynamic instability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
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.
PMID: 24621999DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michael A. Fifer, MD
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Michael A Fifer, MD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Hypertrophic Cardiomyopathy Program
Study Record Dates
First Submitted
June 22, 2010
First Posted
June 25, 2010
Study Start
February 1, 2007
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
September 5, 2013
Results First Posted
September 5, 2013
Record last verified: 2013-09