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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01447654
First Posted: October 6, 2011
Last Update Posted: July 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Henning Bundgaard, Rigshospitalet, Denmark
  Purpose

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 Intervention Phase
Hypertrophic Cardiomyopathy Drug: Losartan Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Henning Bundgaard, Rigshospitalet, Denmark:

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


Enrollment: 130
Study Start Date: November 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Losartan Drug: Losartan
100 mg for 12 months.
Placebo Comparator: Placebo Drug: Placebo
100 mg for 12 months.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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):
Responsible Party: Henning Bundgaard, Consultant, dr. med., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01447654     History of Changes
Other Study ID Numbers: 2011-001191-19
First Submitted: October 4, 2011
First Posted: October 6, 2011
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:
Cardiomyopathy, Hypertrophic
Cardiomyopathies
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