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

• Register: EUCTR
• Last refreshed on: 7 September 2015
• Main ID: EUCTR2011-001191-19-DK
• Date of registration: 12/09/2011
• Prospective Registration: Yes
• Primary sponsor: Hjertemedicinsk klinik B, 2142, Rigshospitalet
• Public title: Effects on the heart in patients with hypertophic cardiomyopathy when treated with losartan.
• Scientific title: Cardiac effects of inhibition of the renin angiotensin system with losartan in patients with hypertrophic cardiomyopathy.
• Date of first enrolment: 26/10/2011
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001191-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Denmark

Contacts

• Name: Henning Bundgaard
• Affiliation: Hjertemedicinsk klinik B, 2142, Rigshospitalet

• Name: Henning Bundgaard
• Affiliation: Hjertemedicinsk klinik B, 2142, Rigshospitalet

Key inclusion & exclusion 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:
- 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

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

Primary Outcome(s)

Primary end point(s): Left ventricular mass

Timepoint(s) of evaluation of this end point: 12 months

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

Secondary Outcome(s)

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

Secondary ID(s)

2011-400

Source(s) of Monetary Support

Region H