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Completed

NCT Number: NCT00185250

Betaferon/ Betaseron (Interferon Beta-1b) in Patients With Chronic Viral Cardiomyopathy

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.

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Key information

Conditions

Cardiomyopathies Adenoviridae Infections Cardiovascular Diseases DNA Virus Infections Enterovirus Infections Heart Diseases Infections Parvoviridae Infections Picornaviridae Infections RNA Virus Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nantes, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)

Drug

2 MIU per application in week 1 and 4 MIU per application in weeks 2 to 24 given subcutaneously every other day

Placebo

Drug

0.25 ml in week 1 and 0.50 ml in weeks 2 to 24 given subcutaneously every other day

Primary outcomes

  1. Presence of Adenovirus, Enterovirus and/or Parvovirus in endomyocardium

    Time frame: 12 weeks after the end of a 24 weeks treatment

Secondary outcomes

  1. Changes in NYHA functional class

    Time frame: 12 weeks and 24 weeks after the end of treatment

  2. Six-minute walking test

    Time frame: 12 weeks and 24 weeks after the end of treatment

  3. Single clinical symptoms (dyspnea, fatigue, palpitation, atypical angina and angina pectoris)

    Time frame: 12 weeks and 24 weeks after the end of treatment

  4. Quality of life

    Time frame: 12 weeks and 24 weeks after the end of treatment

  5. Left ventricular ejection fraction at rest and on exertion

    Time frame: 12 weeks after the end of treatment

  6. Regional and global wall motion, left ventricular enddiastolic diameter, and left ventricular endsystolic diameter

    Time frame: 12 weeks after the end of treatment

  7. Inflammatory state in endomyocardial biopsies

    Time frame: 12 weeks after the end of treatment

  8. Peripheral blood analyses for viral treatment effect and disease markers

    Time frame: 12 weeks after the end of treatment

  9. Composite clinical endpoint

    Time frame: 12 weeks and 24 weeks after the end of treatment

  10. Hemodynamics

    Time frame: 12 weeks after the end of treatment

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
Dec 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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