Inhibition of the Renin Angiotensin System With Losartan in Patients With Hypertrophic Cardiomyopathy (INHERIT)

This study has been completed.

Sponsor:

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

History of Changes

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

Drug Information available for: Losartan Losartan potassium

Genetic and Rare Diseases Information Center resources: Aortic Valve Stenosis

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

Locations


Denmark
Department of cardiology, Rigshospitalet.
Copenhagen, Denmark, 2100

Sponsors and Collaborators

Henning Bundgaard

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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 Hypertrophy Cardiomyopathy, Hypertrophic 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

ClinicalTrials.gov processed this record on September 30, 2016

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