- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01447654
Inhibition of the Renin Angiotensin System With Losartan in Patients With Hypertrophic Cardiomyopathy (INHERIT)
INHibition of the Renin Angiotensin System in Hypertrophic Cardiomyopathy and the Effect on Ventricular Hypertrophy - a Randomized Intervention Trial With Losartan.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark, 2100
- Department of cardiology, Rigshospitalet.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hypertrophic cardiomyopathy
- > 18 years
- Sinus rhythm
Exclusion Criteria:
- EF < 50 %
- Treatment with RAS-inhibitor
- Contraindications to losartan
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
100 mg for 12 months.
|
Active Comparator: Losartan
|
100 mg for 12 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hypertrophy of left ventricle
Time Frame: 12 months
|
Left ventricular mass.
Maximal wall thickness.
|
12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Axelsson A, Iversen K, Vejlstrup N, Ho CY, Havndrup O, Kofoed KF, Norsk J, Jensen M, Bundgaard H. Functional effects of losartan in hypertrophic cardiomyopathy-a randomised clinical trial. Heart. 2016 Feb 15;102(4):285-91. doi: 10.1136/heartjnl-2015-308343. Epub 2015 Dec 9.
- Axelsson A, Iversen K, Vejlstrup N, Ho C, Norsk J, Langhoff L, Ahtarovski K, Corell P, Havndrup O, Jensen M, Bundgaard H. Efficacy and safety of the angiotensin II receptor blocker losartan for hypertrophic cardiomyopathy: the INHERIT randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2015 Feb;3(2):123-31. doi: 10.1016/S2213-8587(14)70241-4. Epub 2014 Dec 19.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Pathological Conditions, Anatomical
- Aortic Valve Disease
- Heart Valve Diseases
- Aortic Stenosis, Subvalvular
- Aortic Valve Stenosis
- Hypertrophy
- Cardiomyopathies
- Cardiomyopathy, Hypertrophic
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Losartan
Other Study ID Numbers
- 2011-001191-19
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertrophic Cardiomyopathy
-
French Cardiology SocietyCompleted1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy | 2- Obstructive Hypertrophic Cardiomyopathy | 3- Non Obstructive Hypertrophic CardiomyopathyFrance
-
University of Sao PauloCompletedNon-obstructive Hypertrophic Cardiomyopathy | Obstructive Hypertrophic CardiomyopathyBrazil
-
Montreal Heart InstituteCanadian Institutes of Health Research (CIHR)Enrolling by invitationCardiomyopathies | Hypertrophic Cardiomyopathy | Hypertrophic Obstructive Cardiomyopathy | Familial Hypertrophic CardiomyopathyCanada
-
Bristol-Myers SquibbActive, not recruitingHypertrophic Cardiomyopathy | Non-obstructive Hypertrophic Cardiomyopathy | Obstructive Hypertrophic CardiomyopathyDenmark, United States, Belgium, Czechia, France, Germany, Israel, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom
-
Yonsei UniversityCompletedFamilial Hypertrophic CardiomyopathyKorea, Republic of
-
Hangzhou Valgen Medtech Co., LtdNot yet recruitingObstructive Hypertrophic CardiomyopathyChina
-
China National Center for Cardiovascular DiseasesNot yet recruitingObstructive Hypertrophic Cardiomyopathy
-
Bristol-Myers SquibbNot yet recruitingObstructive Hypertrophic CardiomyopathyKorea, Republic of
-
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.RecruitingObstructive Hypertrophic CardiomyopathyChina
-
Xiang WeiRecruitingNonobstructive Hypertrophic CardiomyopathyChina
Clinical Trials on Losartan
-
Baker Heart and Diabetes InstituteWithdrawn
-
National Institute of Diabetes and Digestive and...Johns Hopkins UniversityTerminatedNAFLD - Nonalcoholic Fatty Liver DiseaseUnited States
-
Chinese PLA General HospitalTianjin TongRenTang Group Co., Ltd.UnknownProteinuria | GlomerulonephritisChina
-
University of South FloridaNational Cancer Institute (NCI)CompletedPrecancerous ConditionUnited States
-
Organon and CoTerminated
-
Vifor PharmaCompleted
-
Dong Wha Pharmaceutical Co. Ltd.Completed
-
EMSSuspended
-
University of MiamiNational Heart, Lung, and Blood Institute (NHLBI); Flight Attendant Medical...TerminatedCOPD | Chronic BronchitisUnited States