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CompletedNCT01447654INHERITUpdated Jul 9, 2014

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

A Phase 2 interventional study of Losartan and Placebo in Hypertrophic Cardiomyopathy, sponsored by Henning Bundgaard. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-09.

Sponsored by Henning Bundgaard · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertrophic Cardiomyopathy

Keywords

  • Hypertrophic cardiomyopathy
  • Hypertrophic obstructive cardiomyopathy
  • Hypertrophy
  • Losartan
  • Angiotensin II receptor antagonist
03

In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's enrollment of 130 is above the median of 51 across 609 interventional studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

Henning Bundgaard is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Hypertrophic cardiomyopathy
  • > 18 years
  • Sinus rhythm

Exclusion criteria

Exclusion Criteria:

  • EF \< 50 %
  • Treatment with RAS-inhibitor
  • Contraindications to losartan
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
130 participants (actual)

Study arms

  • Active comparator
    Losartan

    Drug: Losartan

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugLosartan

    100 mg for 12 months.

  • DrugPlacebo

    100 mg for 12 months.

06

What researchers measure

Primary outcomes

  1. Hypertrophy of left ventricle

    Left ventricular mass. Maximal wall thickness.

    Time frame: 12 months

07

Study locations

1 site
  • Department of cardiology, Rigshospitalet.
    Copenhagen, 2100, Denmark
08

References and documents

Publications

  • Axelsson A, Iversen K, Vejlstrup N, Ho CY, Havndrup O, Kofoed KF, Norsk J, Jensen M, Bundgaard H. Functional effects of losartan in hypertrophic cardiomyopathy-a randomised clinical trial. Heart. 2016 Feb 15;102(4):285-91. doi: 10.1136/heartjnl-2015-308343. Epub 2015 Dec 9. PubMed 26661322 ↗
  • Axelsson A, Iversen K, Vejlstrup N, Ho C, Norsk J, Langhoff L, Ahtarovski K, Corell P, Havndrup O, Jensen M, Bundgaard H. Efficacy and safety of the angiotensin II receptor blocker losartan for hypertrophic cardiomyopathy: the INHERIT randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2015 Feb;3(2):123-31. doi: 10.1016/S2213-8587(14)70241-4. Epub 2014 Dec 19. PubMed 25533774 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01447654
Lead sponsor
Henning Bundgaard
Responsible party
Henning Bundgaard (Consultant, dr. med., Rigshospitalet, Denmark) — Sponsor-investigator
First posted
Oct 6, 2011
Start date
Nov 2011
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Jul 9, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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