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

Phase 2

Completed

• Conditions: Hypertrophic Cardiomyopathy
• Interventions: Drug: Placebo; Drug: Losartan

• Registration Number: NCT01447654
• Lead Sponsor: Henning Bundgaard

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-04
• Study First Submitted QC: 2011-10-05
• Study First Posted: 2011-10-06
• Study Start: 2011-11
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-08
• Last Update Posted: 2014-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Hypertrophic cardiomyopathy
• > 18 years
• Sinus rhythm

Exclusion Criteria

• EF < 50 %
• Treatment with RAS-inhibitor
• Contraindications to losartan

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Losartan	Losartan	-

Primary Outcome Measures

Name	Time	Method
Hypertrophy of left ventricle	12 months	Left ventricular mass. Maximal wall thickness.

Trial Locations

Locations (1)

Department of cardiology, Rigshospitalet.; 🇩🇰 Copenhagen, Denmark