NCT01447654

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2011

Completed
26 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 9, 2014

Status Verified

July 1, 2014

Enrollment Period

2.6 years

First QC Date

October 4, 2011

Last Update Submit

July 8, 2014

Conditions

Hypertrophic Cardiomyopathy

Keywords

Hypertrophic cardiomyopathyHypertrophic obstructive cardiomyopathyHypertrophyLosartanAngiotensin II receptor antagonist

Outcome Measures

Primary Outcomes (1)

  • Hypertrophy of left ventricle

    Left ventricular mass. Maximal wall thickness.

    12 months

Study Arms (2)

Losartan

ACTIVE COMPARATOR
Drug: Losartan

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

LosartanDRUG

100 mg for 12 months.

Losartan
PlaceboDRUG

100 mg for 12 months.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypertrophic cardiomyopathy
  • \> 18 years
  • Sinus rhythm

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of cardiology, Rigshospitalet.

Copenhagen, 2100, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 26661322DERIVED

  • 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.

    PMID: 25533774DERIVED

MeSH Terms

Conditions

Cardiomyopathy, HypertrophicHypertrophy

Interventions

Losartan

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant, dr. med.

Study Record Dates

First Submitted

October 4, 2011

First Posted

October 6, 2011

Study Start

November 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 9, 2014

Record last verified: 2014-07

Locations

DK(1)