Valsartan on top of standard therapy as a novel therapeutic strategy to treat cardiac dysfunction in patients with infammatory cardiomyopathies - NOVE
- Conditions
- patients suffering from heartfailure and inflammatory cardiomyopthies
- Registration Number
- EUCTR2006-006611-68-NL
- Lead Sponsor
- academic hospital Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
patients < 70 years old
left ventricular (LV) dysfunction of unknown origin (ejection fraction < 50%) or doxorubicin-induced CMP
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Familial forms of dilated CMP
important ethyl abuses (>/= 4 units per day)
ischemic or coronary heart disease
valvular CMP
hypertension, with systolic bloodpressure > 150 mmHg
severe kidney or liver failure
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Investigate whether Valsartan may improve cardiac function in idiopathic inflammatory or DOX-CMPs by performing a prospective randomized open blinded end-point study in these patiens;Secondary Objective: investigate whether Valsartan compared to control reduces local and systemic inflammation local fibrosis and adverse matrix remodeling;Primary end point(s): absolute change in ejection fraction at 6 months versus baseline, measured by echocardiography and CMR
- Secondary Outcome Measures
Name Time Method