Chronic viral cardiomyopathy is a disease where the cardiac muscle is attacked by a virus and this may result in a reduction in the output of the heart (pump function) thereby causing complaints such as chest pain, shortness of breath and palpitations. Betaferon (interferon beta-1b) is marketed for the treatment of Multiple Sclerosis already, but until now, it has not been proven whether it is also effective in patients with chronic viral myocardial disease. This study will be conducted to examine the efficacy and safety of Betaferon in patients with this disease. The aim of the treatment is to eliminate the virus from the heart so that the heart function and clinical status can gradually improve.
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
138
2 MIU per application in week 1 and 4 MIU per application in weeks 2 to 24 given subcutaneously every other day
2 MIU per application in week 1, 4 MIU per application in weeks 2 to 3 and 8 MIU per application in weeks 4 to 24 given subcutaneously every other day
0.25 ml in week 1 and 0.50 ml in weeks 2 to 24 given subcutaneously every other day
0.25 ml in week 1, 0.50 ml in weeks 2 to 3 and 1.00 ml in weeks 4 to 24 given subcutaneously every other day
Unnamed facility
Nantes, France
Unnamed facility
Poitiers, France
Unnamed facility
Bad Krozingen, Baden-Wurttemberg, Germany
Unnamed facility
Ulm, Baden-Wurttemberg, Germany
Unnamed facility
München, Bavaria, Germany
Unnamed facility
Brandenburg, Brandenburg, Germany
Unnamed facility
Hamburg, Hamburg, Germany
Unnamed facility
Göttingen, Lower Saxony, Germany
Unnamed facility
Greifswald, Mecklenburg-Vorpommern, Germany
Unnamed facility
Rostock, Mecklenburg-Vorpommern, Germany
...and 21 more locations
Presence of Adenovirus, Enterovirus and/or Parvovirus in endomyocardium
Time frame: 12 weeks after the end of a 24 weeks treatment
Changes in NYHA functional class
Time frame: 12 weeks and 24 weeks after the end of treatment
Six-minute walking test
Time frame: 12 weeks and 24 weeks after the end of treatment
Single clinical symptoms (dyspnea, fatigue, palpitation, atypical angina and angina pectoris)
Time frame: 12 weeks and 24 weeks after the end of treatment
Quality of life
Time frame: 12 weeks and 24 weeks after the end of treatment
Left ventricular ejection fraction at rest and on exertion
Time frame: 12 weeks after the end of treatment
Regional and global wall motion, left ventricular enddiastolic diameter, and left ventricular endsystolic diameter
Time frame: 12 weeks after the end of treatment
Inflammatory state in endomyocardial biopsies
Time frame: 12 weeks after the end of treatment
Peripheral blood analyses for viral treatment effect and disease markers
Time frame: 12 weeks after the end of treatment
Composite clinical endpoint
Time frame: 12 weeks and 24 weeks after the end of treatment
Hemodynamics
Time frame: 12 weeks after the end of treatment
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