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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Henning Bundgaard, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01447654
First received: October 4, 2011
Last updated: July 8, 2014
Last verified: July 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Hypertrophy of left ventricle [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447654

Locations
Denmark
Department of cardiology, Rigshospitalet.
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Henning Bundgaard
  More Information

No publications provided

Responsible Party: Henning Bundgaard, Consultant, dr. med., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01447654     History of Changes
Other Study ID Numbers: 2011-001191-19
Study First Received: October 4, 2011
Last Updated: July 8, 2014
Health Authority: Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Hypertrophic cardiomyopathy
Hypertrophic obstructive cardiomyopathy
Hypertrophy
Losartan
Angiotensin II receptor antagonist

Additional relevant MeSH terms:
Cardiomyopathy, Hypertrophic
Hypertrophy
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Pathological Conditions, Anatomical
Losartan
Angiotensin Receptor Antagonists
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014