Trial Condition(s):
Cardiomyopathies, Heart Diseases
Betaferon/ Betaseron (Interferon beta-1b) in patients with chronic viral cardiomyopathy
Bayer Identifier:
91115
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Charité Campus Benjamin Franklin Berlin, Germany, 12200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario San Carlos Madrid, Spain, 28040 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Ernst-Moritz-Arndt-Universität Greifswald, Germany, 17489 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bereich Humanmed. d. Georg-August-Universität Göttingen Göttingen, Germany, 37075 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Städtisches Klinikum Brandenburg GmbH Brandenburg, Germany, 14770 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen, Germany, 67063 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Münster Münster, Germany, 48149 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Wuppertal GmbH Wuppertal, Germany, 42117 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Christian-Albrechts-Universität Kiel, Germany, 24105 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Einrichtungen der Universität zu Köln Köln, Germany, 50931 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätskliniken des Saarlandes Homburg, Germany, 66421 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Glasgow Western Infirmary Glasgow, United Kingdom, G11 6NT | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedale San Raffaele Milano, Italy, 20132 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sahlgrenska Universitetssjukhuset Göteborg, Sweden, 413 45 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Einrichtungen der Universität Essen Essen, Germany, 45147 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universität Leipzig Leipzig, Germany, 04103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Ulm Ulm, Germany, 89075 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Herz- und Diabeteszentrum Nordrhein-Westfalen Bad Oeynhausen, Germany, 32545 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Zentralklinik Bad Berka GmbH Bad Berka, Germany, 99437 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitäts-Krankenhaus Eppendorf Hamburg, Germany, 20251 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Deutsches Herzzentrum München München, Germany, 80636 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Martin-Luther-Universität Halle-Wittenberg Halle, Germany, 06097 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universität Rostock - Medizinische Fakultät Rostock, Germany, 18057 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Herzzentrum Bad Krozingen Bad Krozingen, Germany, 79189 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St.-Johannes-Hospital Dortmund Dortmund, Germany, 44137 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedali Riuniti di Bergamo Bergamo, Italy, 24128 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Università di Pavia Pavia, Italy, 27100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre René Gauducheau Nantes, France, 44805 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier Universitaire - Poitiers POITIERS CEDEX, France, 86021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojskowy Instytut Medyczny Warszawa, Poland, 00-909 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institut of Cardiology Warszawa, Poland, 04628 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Double-blind, placebo-controlled, randomized, parallel group, multicenter study to evaluate efficacy and safety of 4 and 8 million units Betaferon®/Betaseron® (Interferon beta-1b) given subcutaneously every other day over 24 weeks in patients with chronic viral cardiomyopathy
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- Presence of Adenovirus, Enterovirus and/or Parvovirus in endomyocardiumTimeframe: 12 weeks after the end of a 24 weeks treatment
Secondary Outcome
- Changes in NYHA functional classTimeframe: 12 weeks and 24 weeks after the end of treatment
- Six-minute walking testTimeframe: 12 weeks and 24 weeks after the end of treatment
- Single clinical symptoms (dyspnea, fatigue, palpitation, atypical angina and angina pectoris)Timeframe: 12 weeks and 24 weeks after the end of treatment
- Quality of lifeTimeframe: 12 weeks and 24 weeks after the end of treatment
- Left ventricular ejection fraction at rest and on exertionTimeframe: 12 weeks after the end of treatment
- Regional and global wall motion, left ventricular enddiastolic diameter, and left ventricular endsystolic diameterTimeframe: 12 weeks after the end of treatment
- Inflammatory state in endomyocardial biopsiesTimeframe: 12 weeks after the end of treatment
- Peripheral blood analyses for viral treatment effect and disease markersTimeframe: 12 weeks after the end of treatment
- Composite clinical endpointTimeframe: 12 weeks and 24 weeks after the end of treatment
- HemodynamicsTimeframe: 12 weeks after the end of treatment
Additional Information
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