Cardiomyopathies, Heart Diseases
Conditions
Keywords
Cardiomyopathy, idiopathic chronic heart failure, Adenovirus, Enterovirus, Parvovirus
Brief summary
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.
Detailed description
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.
Interventions
2 MIU per application in week 1 and 4 MIU per application in weeks 2 to 24 given subcutaneously every other day
DRUGPlacebo
0.25 ml in week 1 and 0.50 ml in weeks 2 to 24 given subcutaneously every other day
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Unexplained heart with evidence of Adeno-, Entero- and/or Parvoviruses which must be identified directly in the heart tissue * Being in a chronic (at least 6 month after the onset of clinical symptoms) and stable phase of the disease * Impaired cardiac function
Exclusion criteria
* Severe (decompensated) or acute heart failure. * Any other disease which could better explain the patient's clinical symptoms * Any other severe and/or malignant disease. * Suffering from convulsions, depression or suicidal ideas judged by a physician * Serious viral or bacterial infections during the last weeks * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of Adenovirus, Enterovirus and/or Parvovirus in endomyocardium | 12 weeks after the end of a 24 weeks treatment |
Secondary
| Measure | Time frame |
|---|---|
| Six-minute walking test | 12 weeks and 24 weeks after the end of treatment |
| Single clinical symptoms (dyspnea, fatigue, palpitation, atypical angina and angina pectoris) | 12 weeks and 24 weeks after the end of treatment |
| Quality of life | 12 weeks and 24 weeks after the end of treatment |
| Left ventricular ejection fraction at rest and on exertion | 12 weeks after the end of treatment |
| Changes in NYHA functional class | 12 weeks and 24 weeks after the end of treatment |
| Inflammatory state in endomyocardial biopsies | 12 weeks after the end of treatment |
| Peripheral blood analyses for viral treatment effect and disease markers | 12 weeks after the end of treatment |
| Composite clinical endpoint | 12 weeks and 24 weeks after the end of treatment |
| Hemodynamics | 12 weeks after the end of treatment |
| Regional and global wall motion, left ventricular enddiastolic diameter, and left ventricular endsystolic diameter | 12 weeks after the end of treatment |
Countries
France, Germany, Italy, Poland, Spain, Sweden, United Kingdom
Outcome results
None listed