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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
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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
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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

MedlinePlus related topics: Cardiomyopathy

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Hypertrophy of left ventricle [ Time Frame: 12 months ]
    Left ventricular mass. Maximal wall thickness.


Eligibility Criteria
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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
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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
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Denmark
Department of cardiology, Rigshospitalet.
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Henning Bundgaard
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Henning Bundgaard, Consultant, dr. med., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01447654    
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:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
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