Inhibition of the Renin Angiotensin System With Losartan in Patients With Hypertrophic Cardiomyopathy
NCT ID: NCT01447654
Last Updated: 2014-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
130 participants
INTERVENTIONAL
2011-11-30
2014-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Losartan
Losartan
100 mg for 12 months.
Placebo
Placebo
100 mg for 12 months.
Interventions
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Losartan
100 mg for 12 months.
Placebo
100 mg for 12 months.
Eligibility Criteria
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Inclusion Criteria
* \> 18 years
* Sinus rhythm
Exclusion Criteria
* Treatment with RAS-inhibitor
* Contraindications to losartan
18 Years
ALL
No
Sponsors
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Henning Bundgaard
OTHER
Responsible Party
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Henning Bundgaard
Consultant, dr. med.
Locations
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Department of cardiology, Rigshospitalet.
Copenhagen, , Denmark
Countries
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References
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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.
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.
Other Identifiers
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2011-001191-19
Identifier Type: -
Identifier Source: org_study_id
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