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
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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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Losartan |
Drug: Losartan
100 mg for 12 months. |
Placebo Comparator: Placebo |
Drug: Placebo
100 mg for 12 months. |
- Hypertrophy of left ventricle [ Time Frame: 12 months ]Left ventricular mass. Maximal wall thickness.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Hypertrophic cardiomyopathy
- > 18 years
- Sinus rhythm
Exclusion Criteria:
- EF < 50 %
- Treatment with RAS-inhibitor
- Contraindications to losartan

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
Denmark | |
Department of cardiology, Rigshospitalet. | |
Copenhagen, Denmark, 2100 |
Responsible Party: | Henning Bundgaard, Consultant, dr. med., Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT01447654 |
Other Study ID Numbers: |
2011-001191-19 |
First Posted: | October 6, 2011 Key Record Dates |
Last Update Posted: | July 9, 2014 |
Last Verified: | July 2014 |
Hypertrophic cardiomyopathy Hypertrophic obstructive cardiomyopathy Hypertrophy Losartan Angiotensin II receptor antagonist |
Cardiomyopathies Cardiomyopathy, Hypertrophic Hypertrophy Heart Diseases Cardiovascular Diseases Pathological Conditions, Anatomical Aortic Stenosis, Subvalvular Aortic Valve Stenosis |
Heart Valve Diseases Losartan Anti-Arrhythmia Agents Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |