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

NCT ID: NCT01447654

Last Updated: 2014-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertrophic Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Losartan

Group Type ACTIVE_COMPARATOR

Losartan

Intervention Type DRUG

100 mg for 12 months.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

100 mg for 12 months.

Interventions

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Losartan

100 mg for 12 months.

Intervention Type DRUG

Placebo

100 mg for 12 months.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hypertrophic cardiomyopathy
* \> 18 years
* Sinus rhythm

Exclusion Criteria

* EF \< 50 %
* Treatment with RAS-inhibitor
* Contraindications to losartan
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henning Bundgaard

OTHER

Sponsor Role lead

Responsible Party

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Henning Bundgaard

Consultant, dr. med.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of cardiology, Rigshospitalet.

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 26661322 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25533774 (View on PubMed)

Other Identifiers

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2011-001191-19

Identifier Type: -

Identifier Source: org_study_id

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