Inhibition of the Renin Angiotensin System With Losartan in Patients With Hypertrophic Cardiomyopathy (INHERIT)
This study has been completed.
Sponsor:
Henning Bundgaard
Information provided by (Responsible Party):
Henning Bundgaard, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01447654
First received: October 4, 2011
Last updated: July 8, 2014
Last verified: July 2014
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Hypertrophic Cardiomyopathy |
Drug: Losartan Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial hypertrophic cardiomyopathy
supravalvular aortic stenosis
MedlinePlus related topics:
Cardiomyopathy
U.S. FDA Resources
Further study details as provided by Rigshospitalet, Denmark:
Primary Outcome Measures:
- Hypertrophy of left ventricle [ Time Frame: 12 months ] [ Designated as safety issue: No ]Left ventricular mass. Maximal wall thickness.
| Enrollment: | 130 |
| Study Start Date: | November 2011 |
| Study Completion Date: | June 2014 |
| Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Losartan |
Drug: Losartan
100 mg for 12 months.
|
| Placebo Comparator: Placebo |
Drug: Placebo
100 mg for 12 months.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Hypertrophic cardiomyopathy
- > 18 years
- Sinus rhythm
Exclusion Criteria:
- EF < 50 %
- Treatment with RAS-inhibitor
- Contraindications to losartan
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447654
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447654
Locations
| Denmark | |
| Department of cardiology, Rigshospitalet. | |
| Copenhagen, Denmark, 2100 | |
Sponsors and Collaborators
Henning Bundgaard
More Information
No publications provided
| Responsible Party: | Henning Bundgaard, Consultant, dr. med., Rigshospitalet, Denmark |
| ClinicalTrials.gov Identifier: | NCT01447654 History of Changes |
| Other Study ID Numbers: | 2011-001191-19 |
| Study First Received: | October 4, 2011 |
| Last Updated: | July 8, 2014 |
| Health Authority: | Denmark: Danish Medicines Agency Denmark: The Regional Committee on Biomedical Research Ethics Denmark: Danish Dataprotection Agency |
Keywords provided by Rigshospitalet, Denmark:
|
Hypertrophic cardiomyopathy Hypertrophic obstructive cardiomyopathy Hypertrophy Losartan Angiotensin II receptor antagonist |
Additional relevant MeSH terms:
|
Cardiomyopathies Cardiomyopathy, Hypertrophic Hypertrophy Aortic Stenosis, Subvalvular Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Pathological Conditions, Anatomical |
Losartan Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Anti-Arrhythmia Agents Antihypertensive Agents Cardiovascular Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015