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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cardiomyopathies, Heart Diseases

Intervention / Treatment
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* Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
* Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
* Drug: Placebo
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)<br>* 2 MIU per application in week 1 and 4 MIU per application in weeks 2 to 24 given subcutaneously every other day<br>|
| Experimental: Arm 2<br> | Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)<br>* 2 MIU per application in week 1, 4 MIU per application in weeks 2 to 3 and 8 MIU per application in weeks 4 to 24 given subcutaneously every other day<br>|
| Placebo Comparator: Arm 3<br> | Drug: Placebo<br>* 0.25 ml in week 1 and 0.50 ml in weeks 2 to 24 given subcutaneously every other day<br>|
| Placebo Comparator: Arm 4<br> | Drug: Placebo<br>* 0.25 ml in week 1, 0.50 ml in weeks 2 to 3 and 1.00 ml in weeks 4 to 24 given subcutaneously every other day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Adenovirus, Enterovirus and/or Parvovirus in endomyocardium |  | 12 weeks after the end of a 24 weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Hemodynamics |  | 12 weeks after the end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiomyopathy, idiopathic chronic heart failure, Adenovirus, Enterovirus, Parvovirus