check_circleStudy Completed

Cardiomyopathies, Heart Diseases

Bayer Identifier:

91115

ClinicalTrials.gov Identifier:

NCT00185250

EudraCT Number:

Not Available

EU CT Number:

Not Available
Betaferon/ Betaseron (Interferon beta-1b) in patients with chronic viral cardiomyopathy

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.

Key Participants Requirements

Sex

Both

Age

18 - 75 Years
  • - 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
  • - 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
December 2002 - November 2005
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Charité Campus Benjamin FranklinBerlin, 12200, Germany
Completed
Hospital Clínico Universitario San CarlosMadrid, 28040, Spain
Completed
Klinikum der Ernst-Moritz-Arndt-UniversitätGreifswald, 17489, Germany
Completed
Bereich Humanmed. d. Georg-August-Universität GöttingenGöttingen, 37075, Germany
Completed
Städtisches Klinikum Brandenburg GmbHBrandenburg, 14770, Germany
Completed
Klinikum der Stadt Ludwigshafen am Rhein gGmbHLudwigshafen, 67063, Germany
Completed
Universitätsklinikum MünsterMünster, 48149, Germany
Completed
Klinikum Wuppertal GmbHWuppertal, 42117, Germany
Completed
Klinikum der Christian-Albrechts-UniversitätKiel, 24105, Germany
Completed
Medizinische Einrichtungen der Universität zu KölnKöln, 50931, Germany
Completed
Universitätskliniken des SaarlandesHomburg, 66421, Germany
Completed
Glasgow Western InfirmaryGlasgow, G11 6NT, United Kingdom
Completed
Ospedale San RaffaeleMilano, 20132, Italy
Completed
Sahlgrenska UniversitetssjukhusetGöteborg, 413 45, Sweden
Completed
Medizinische Einrichtungen der Universität EssenEssen, 45147, Germany
Completed
Universität LeipzigLeipzig, 04103, Germany
Completed
Universitätsklinikum UlmUlm, 89075, Germany
Completed
Herz- und Diabeteszentrum Nordrhein-WestfalenBad Oeynhausen, 32545, Germany
Completed
Zentralklinik Bad Berka GmbHBad Berka, 99437, Germany
Completed
Universitäts-Krankenhaus EppendorfHamburg, 20251, Germany
Completed
Deutsches Herzzentrum MünchenMünchen, 80636, Germany
Completed
Martin-Luther-Universität Halle-WittenbergHalle, 06097, Germany
Completed
Universität Rostock - Medizinische FakultätRostock, 18057, Germany
Completed
Herzzentrum Bad KrozingenBad Krozingen, 79189, Germany
Completed
St.-Johannes-Hospital DortmundDortmund, 44137, Germany
Completed
Ospedali Riuniti di BergamoBergamo, 24128, Italy
Completed
Università di PaviaPavia, 27100, Italy
Completed
Centre René GauducheauNantes, 44805, France
Completed
Centre Hospitalier Universitaire - PoitiersPOITIERS CEDEX, 86021, France
Completed
Wojskowy Instytut MedycznyWarszawa, 00-909, Poland
Completed
Institut of CardiologyWarszawa, 04628, Poland

Primary Outcome

  • Presence of Adenovirus, Enterovirus and/or Parvovirus in endomyocardium
    date_rangeTime Frame:
    12 weeks after the end of a 24 weeks treatment
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Changes in NYHA functional class
    date_rangeTime Frame:
    12 weeks and 24 weeks after the end of treatment
    enhanced_encryption
    Safety Issue:
    no
  • Six-minute walking test
    date_rangeTime Frame:
    12 weeks and 24 weeks after the end of treatment
    enhanced_encryption
    Safety Issue:
    no
  • Single clinical symptoms (dyspnea, fatigue, palpitation, atypical angina and angina pectoris)
    date_rangeTime Frame:
    12 weeks and 24 weeks after the end of treatment
    enhanced_encryption
    Safety Issue:
    no
  • Quality of life
    date_rangeTime Frame:
    12 weeks and 24 weeks after the end of treatment
    enhanced_encryption
    Safety Issue:
    no
  • Left ventricular ejection fraction at rest and on exertion
    date_rangeTime Frame:
    12 weeks after the end of treatment
    enhanced_encryption
    Safety Issue:
    no
  • Regional and global wall motion, left ventricular enddiastolic diameter, and left ventricular endsystolic diameter
    date_rangeTime Frame:
    12 weeks after the end of treatment
    enhanced_encryption
    Safety Issue:
    no
  • Inflammatory state in endomyocardial biopsies
    date_rangeTime Frame:
    12 weeks after the end of treatment
    enhanced_encryption
    Safety Issue:
    no
  • Peripheral blood analyses for viral treatment effect and disease markers
    date_rangeTime Frame:
    12 weeks after the end of treatment
    enhanced_encryption
    Safety Issue:
    no
  • Composite clinical endpoint
    date_rangeTime Frame:
    12 weeks and 24 weeks after the end of treatment
    enhanced_encryption
    Safety Issue:
    no
  • Hemodynamics
    date_rangeTime Frame:
    12 weeks after the end of treatment
    enhanced_encryption
    Safety Issue:
    no

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

Additional Information

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