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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Henning Bundgaard, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01447654
First received: October 4, 2011
Last updated: June 10, 2013
Last verified: June 2013

October 4, 2011
June 10, 2013
November 2011
June 2014   (final data collection date for primary outcome measure)
Hypertrophy of left ventricle [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Left ventricular mass. Maximal wall thickness.
Left ventricular mass [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01447654 on ClinicalTrials.gov Archive Site
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Inhibition of the Renin Angiotensin System With Losartan in Patients With Hypertrophic Cardiomyopathy
INHibition of the Renin Angiotensin System in Hypertrophic Cardiomyopathy and the Effect on Ventricular Hypertrophy - a Randomized Intervention Trial With Losartan.

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.

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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypertrophic Cardiomyopathy
  • Drug: Losartan
    100 mg for 12 months.
  • Drug: Placebo
    100 mg for 12 months.
  • Active Comparator: Losartan
    Intervention: Drug: Losartan
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
130
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hypertrophic cardiomyopathy
  • > 18 years
  • Sinus rhythm

Exclusion Criteria:

  • EF < 50 %
  • Treatment with RAS-inhibitor
  • Contraindications to losartan
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01447654
2011-001191-19
Yes
Henning Bundgaard, Rigshospitalet, Denmark
Henning Bundgaard
Not Provided
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Rigshospitalet, Denmark
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP