Inhibition of the Renin Angiotensin System With Losartan in Patients With Hypertrophic Cardiomyopathy (INHERIT)
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|ClinicalTrials.gov Identifier: NCT01447654|
Recruitment Status : Completed
First Posted : October 6, 2011
Last Update Posted : July 9, 2014
Objective The objective of the study is to assess the structural and functional cardiac effects of treatment with losartan in patients with hypertrophic cardiomyopathy (HCM).
Design The study is a randomized, placebo‐controlled, double‐blinded trial. The follow‐up period is 12 months. 130 patients with HCM will be included in predefined subgroups. Genotype positive relatives with borderline hypertrophy (> 13 mm) will also be included. Data on individuals with borderline hypertrophy will be analysed separately from the rest of the cohort.
Primary outcome Ventricular hypertrophy assessed as left ventricular mass and maximal wall thickness.
|Condition or disease||Intervention/treatment||Phase|
|Hypertrophic Cardiomyopathy||Drug: Losartan Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||INHibition of the Renin Angiotensin System in Hypertrophic Cardiomyopathy and the Effect on Ventricular Hypertrophy - a Randomized Intervention Trial With Losartan.|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
U.S. FDA Resources
|Active Comparator: Losartan||
100 mg for 12 months.
|Placebo Comparator: Placebo||
100 mg for 12 months.
- Hypertrophy of left ventricle [ Time Frame: 12 months ]Left ventricular mass. Maximal wall thickness.
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): NCT01447654
|Department of cardiology, Rigshospitalet.|
|Copenhagen, Denmark, 2100|