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

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.
 
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

Tracking Information
First Submitted Date  ICMJE October 4, 2011
First Posted Date  ICMJE October 6, 2011
Last Update Posted Date July 9, 2014
Study Start Date  ICMJE November 2011
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2013)
Hypertrophy of left ventricle [ Time Frame: 12 months ]
Left ventricular mass. Maximal wall thickness.
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2011)
Left ventricular mass [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inhibition of the Renin Angiotensin System With Losartan in Patients With Hypertrophic Cardiomyopathy
Official Title  ICMJE INHibition of the Renin Angiotensin System in Hypertrophic Cardiomyopathy and the Effect on Ventricular Hypertrophy - a Randomized Intervention Trial With Losartan.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypertrophic Cardiomyopathy
Intervention  ICMJE
  • Drug: Losartan
    100 mg for 12 months.
  • Drug: Placebo
    100 mg for 12 months.
Study Arms  ICMJE
  • Active Comparator: Losartan
    Intervention: Drug: Losartan
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2013)
130
Original Estimated Enrollment  ICMJE
 (submitted: October 5, 2011)
320
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hypertrophic cardiomyopathy
  • > 18 years
  • Sinus rhythm

Exclusion Criteria:

  • EF < 50 %
  • Treatment with RAS-inhibitor
  • Contraindications to losartan
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01447654
Other Study ID Numbers  ICMJE 2011-001191-19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Henning Bundgaard, Rigshospitalet, Denmark
Study Sponsor  ICMJE Henning Bundgaard
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rigshospitalet, Denmark
Verification Date July 2014

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