Trial Condition(s):

Cardiomyopathies, Heart Diseases

Betaferon/ Betaseron (Interferon beta-1b) in patients with chronic viral cardiomyopathy

Bayer Identifier:

91115

ClinicalTrials.gov Identifier:

NCT00185250

EudraCT Number:

Not Available

Study Completed

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
138
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Charité Campus Benjamin Franklin

Berlin, Germany, 12200

Status
Completed
 
Locations

Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

Status
Completed
 
Locations

Klinikum der Ernst-Moritz-Arndt-Universität

Greifswald, Germany, 17489

Status
Completed
 
Locations

Bereich Humanmed. d. Georg-August-Universität Göttingen

Göttingen, Germany, 37075

Status
Completed
 
Locations

Städtisches Klinikum Brandenburg GmbH

Brandenburg, Germany, 14770

Status
Completed
 
Locations

Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen, Germany, 67063

Status
Completed
 
Locations

Universitätsklinikum Münster

Münster, Germany, 48149

Status
Completed
 
Locations

Klinikum Wuppertal GmbH

Wuppertal, Germany, 42117

Status
Completed
 
Locations

Klinikum der Christian-Albrechts-Universität

Kiel, Germany, 24105

Status
Completed
 
Locations

Medizinische Einrichtungen der Universität zu Köln

Köln, Germany, 50931

Status
Completed
 
Locations

Universitätskliniken des Saarlandes

Homburg, Germany, 66421

Status
Completed
 
Locations

Glasgow Western Infirmary

Glasgow, United Kingdom, G11 6NT

Status
Completed
 
Locations

Ospedale San Raffaele

Milano, Italy, 20132

Status
Completed
 
Locations

Sahlgrenska Universitetssjukhuset

Göteborg, Sweden, 413 45

Status
Completed
 
Locations

Medizinische Einrichtungen der Universität Essen

Essen, Germany, 45147

Status
Completed
 
Locations

Universität Leipzig

Leipzig, Germany, 04103

Status
Completed
 
Locations

Universitätsklinikum Ulm

Ulm, Germany, 89075

Status
Completed
 
Locations

Herz- und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, Germany, 32545

Status
Completed
 
Locations

Zentralklinik Bad Berka GmbH

Bad Berka, Germany, 99437

Status
Completed
 
Locations

Universitäts-Krankenhaus Eppendorf

Hamburg, Germany, 20251

Status
Completed
 
Locations

Deutsches Herzzentrum München

München, Germany, 80636

Status
Completed
 
Locations

Martin-Luther-Universität Halle-Wittenberg

Halle, Germany, 06097

Status
Completed
 
Locations

Universität Rostock - Medizinische Fakultät

Rostock, Germany, 18057

Status
Completed
 
Locations

Herzzentrum Bad Krozingen

Bad Krozingen, Germany, 79189

Status
Completed
 
Locations

St.-Johannes-Hospital Dortmund

Dortmund, Germany, 44137

Status
Completed
 
Locations

Ospedali Riuniti di Bergamo

Bergamo, Italy, 24128

Status
Completed
 
Locations

Università di Pavia

Pavia, Italy, 27100

Status
Completed
 
Locations

Centre René Gauducheau

Nantes, France, 44805

Status
Completed
 
Locations

Centre Hospitalier Universitaire - Poitiers

POITIERS CEDEX, France, 86021

Status
Completed
 
Locations

Wojskowy Instytut Medyczny

Warszawa, Poland, 00-909

Status
Completed
 
Locations

Institut of Cardiology

Warszawa, Poland, 04628

Status
Completed
 

Trial Design