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

Primary Purpose

Hypertrophic Cardiomyopathy

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Losartan
Placebo
Sponsored by
Henning Bundgaard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic Cardiomyopathy focused on measuring Hypertrophic cardiomyopathy, Hypertrophic obstructive cardiomyopathy, Hypertrophy, Losartan, Angiotensin II receptor antagonist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hypertrophic cardiomyopathy
  • > 18 years
  • Sinus rhythm

Exclusion Criteria:

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

Sites / Locations

  • Department of cardiology, Rigshospitalet.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Losartan

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Hypertrophy of left ventricle
Left ventricular mass. Maximal wall thickness.

Secondary Outcome Measures

Full Information

First Posted
October 4, 2011
Last Updated
July 8, 2014
Sponsor
Henning Bundgaard
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1. Study Identification

Unique Protocol Identification Number
NCT01447654
Brief Title
Inhibition of the Renin Angiotensin System With Losartan in Patients With Hypertrophic Cardiomyopathy
Acronym
INHERIT
Official Title
INHibition of the Renin Angiotensin System in Hypertrophic Cardiomyopathy and the Effect on Ventricular Hypertrophy - a Randomized Intervention Trial With Losartan.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Henning Bundgaard

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Cardiomyopathy
Keywords
Hypertrophic cardiomyopathy, Hypertrophic obstructive cardiomyopathy, Hypertrophy, Losartan, Angiotensin II receptor antagonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Losartan
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Losartan
Intervention Description
100 mg for 12 months.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
100 mg for 12 months.
Primary Outcome Measure Information:
Title
Hypertrophy of left ventricle
Description
Left ventricular mass. Maximal wall thickness.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hypertrophic cardiomyopathy > 18 years Sinus rhythm Exclusion Criteria: EF < 50 % Treatment with RAS-inhibitor Contraindications to losartan
Facility Information:
Facility Name
Department of cardiology, Rigshospitalet.
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26661322
Citation
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.
Results Reference
derived
PubMed Identifier
25533774
Citation
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.
Results Reference
derived

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

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