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

Phase 2

Completed

• Conditions: Cardiomyopathies; Heart Diseases
• Interventions: Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046); Drug: Placebo

• Registration Number: NCT00185250
• Lead Sponsor: Bayer

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 Description

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.

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-16
• Study Completion: 2005-11
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-18
• Last Update Posted: 2008-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)	-
Arm 3	Placebo	-
Arm 4	Placebo	-
Arm 1	Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)	-

Primary Outcome Measures

Name	Time	Method
Presence of Adenovirus, Enterovirus and/or Parvovirus in endomyocardium	12 weeks after the end of a 24 weeks treatment

Secondary Outcome Measures

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