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Effects on the heart in patients with hypertophic cardiomyopathy when treated with losartan.

Cardiac effects of inhibition of the renin angiotensin system with losartan in patients with hypertrophic cardiomyopathy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-001191-19-DK
Enrollment
Unknown
Registered
2011-09-12
Start date
2011-10-26
Completion date
Unknown
Last updated
2015-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic cardiomyopathy MedDRA version: 14.0 Level: LLT Classification code 10020876 Term: Hypertrophic obstructive cardiomyopathy System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: Losartan "Bluefish" 50 mg Product Name: Losartan Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Sponsors

Hjertemedicinsk klinik B, 2142, Rigshospitalet
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Known hypertophic cardiomyopathy - > 18 years - Sinus rhythm Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120

Exclusion criteria

Exclusion criteria: - Ejection fraction < 50 % - Treatment with inhibitor of the renin angiotensin system within 3 months - Pregnancy or lactation - Renal insufficiency - Liver insufficiency - Hypotension - Not sufficiently treated hypertesnion - Earlier experinced angioneurotic oedema when treated with inhibitor of the renin angiotensin system - Treatment with Lithium - Expected non-compliance

Design outcomes

Primary

MeasureTime frame
Main Objective: To find out whether treatment with losartan reduces left ventricular mass in patients with hypertrophic cardiomyopathy.;Secondary Objective: To find out whether treatment with losartan - reduces myocardial fibrosis - increases systolic and diastolic funktion - increases work capacity - decreases riskfactors for sudden cardiac death - decreases arrythmias - reduces symptoms of heart failure;Primary end point(s): Left ventricular mass;Timepoint(s) of evaluation of this end point: 12 months—

Secondary

MeasureTime frame
Secondary end point(s): - Thickness of septum - Thckness of left ventricles postrior wall - Fibrosis of left ventricular wall - Gradient in Left ventricular outflow tract - Systolic function of left ventricle - Diastolic function of left ventricle - Left atrial volume - Arythmias - Work load - Blood pressure response - Symptoms of heart failure - Hypertrophy in ECG - NT-pro-BNP - Risk factors of sudden cardiac death - Selfassessed health and life quality - Tolerability;Timepoint(s) of evaluation of this end point: 12 months—

Countries

Denmark

Contacts

Public ContactHenning Bundgaard

Hjertemedicinsk klinik B, 2142, Rigshospitalet

henningbundgaard@dadlnet.dk+4535450512

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026