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

Sponsor:

Information provided by (Responsible Party):

Henning Bundgaard, Rigshospitalet, Denmark

Study Description

Brief Summary:

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 Design


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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Familial hypertrophic cardiomyopathy

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

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Losartan	Drug: Losartan 100 mg for 12 months.
Placebo Comparator: Placebo	Drug: Placebo 100 mg for 12 months.

Outcome Measures

Primary Outcome Measures :

Hypertrophy of left ventricle [ Time Frame: 12 months ]
Left ventricular mass. Maximal wall thickness.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

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

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 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.


Responsible Party:	Henning Bundgaard, Consultant, dr. med., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT01447654 History of Changes
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

Keywords provided by Henning Bundgaard, 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

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