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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official 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 Subc

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 Summary:

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.


Sponsor: Bayer

Current Primary Outcome: Presence of Adenovirus, Enterovirus and/or Parvovirus in endomyocardium [ Time Frame: 12 weeks after the end of a 24 weeks treatment ]

Original Primary Outcome: Presence of Adenovirus, Enterovirus and/or Parvovirus in endomyocardium 12 weeks after the end of a 24 weeks treatment

Current Secondary Outcome:

  • Changes in NYHA functional class [ Time Frame: 12 weeks and 24 weeks after the end of treatment ]
  • Six-minute walking test [ Time Frame: 12 weeks and 24 weeks after the end of treatment ]
  • Single clinical symptoms (dyspnea, fatigue, palpitation, atypical angina and angina pectoris) [ Time Frame: 12 weeks and 24 weeks after the end of treatment ]
  • Quality of life [ Time Frame: 12 weeks and 24 weeks after the end of treatment ]
  • Left ventricular ejection fraction at rest and on exertion [ Time Frame: 12 weeks after the end of treatment ]
  • Regional and global wall motion, left ventricular enddiastolic diameter, and left ventricular endsystolic diameter [ Time Frame: 12 weeks after the end of treatment ]
  • Inflammatory state in endomyocardial biopsies [ Time Frame: 12 weeks after the end of treatment ]
  • Peripheral blood analyses for viral treatment effect and disease markers [ Time Frame: 12 weeks after the end of treatment ]
  • Composite clinical endpoint [ Time Frame: 12 weeks and 24 weeks after the end of treatment ]
  • Hemodynamics [ Time Frame: 12 weeks after the end of treatment ]


Original Secondary Outcome:

  • changes in NYHA functional class at 12 and 24 weeks after the end of treatment
  • composite clinical endpoint at 12 wks and 24 wks after the end of treatment
  • 6-minute walking test at 12 weeks and 24 weeks after the end of treatment
  • single clinical symptoms (dyspnea, fatigue, palpitation, atypical angina and angina pectoris) at 12 weeks and 24 weeks after the end of treatment
  • quality of life at 12 weeks and 24 weeks after the end of treatment
  • left ventricular ejection fraction at rest and on exertion at 12 weeks after the end of treatment
  • regional and global wall motion, left ventricular enddiastolic diameter, and left ventricular endsystolic diameter at 12 weeks after the end of treatment
  • inflammatory state in endomyocardial biopsies at 12 weeks after the end of treatment
  • peripheral blood analyses for viral treatment effect and disease markers at 12 weeks after the end of treatment
  • composite clinical endpoint at 12 weeks and 24 weeks after the end of treatment
  • hemodynamics at 12 weeks after the end of treatment.


Information By: Bayer

Dates:
Date Received: September 10, 2005
Date Started: December 2002
Date Completion:
Last Updated: December 18, 2008
Last Verified: December 2008