Pilot study for evaluation of growth factor erythropoietin beta for improvement of left ventricular function after coronary interventions - EPO in ischemic heart failure
Phase 1
- Conditions
- Ischemic heart failure is a major public health burden in western societies. Although technical advancements have improved recascularization of ischemic heart tissue in recent years, data on functional improvement concerning the left ventricle suggest a need for optimization of pharamcological therapie. The growth hormone erythropoietin beta has been shown to improve heart function in various animal models of ischemic heart disease.
- Registration Number
- EUCTR2004-002646-35-DE
- Lead Sponsor
- Franz Volhard Clinic, Charite Campus Buch
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
patients after succesful percutaneous, coronary interventions, signs of ischemic heart failure and mild anemia.
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
acute cardiogenic shock, contraindictaiosn for MRI, cancer, iron deficiency, pregnancy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To test the effect of a once weekly dose of erythropietin on left ventricular remodelling after coronary intervention.;Secondary Objective: to test for heart failure parameters, bnp levels, exercise tolerance, myocardial fibrosis;Primary end point(s): global ejection fraction in MRI and Echo
- Secondary Outcome Measures
Name Time Method