Clinical trial NCT00185250: Betaferon/ Betaseron (Interferon Beta-1b) in Patients With Chronic Viral Cardiomyopathy
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 Subcutaneously Every Other Day Over 24 Weeks in Patients With Chronic Viral Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiomyopathies
Heart Diseases
Keywords: Cardiomyopathy
idiopathic chronic heart failure
Adenovirus
Enterovirus
Parvovirus
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of Adenovirus, Enterovirus and/or Parvovirus in endomyocardium
timeFrame: 12 weeks after the end of a 24 weeks treatment
Secondary outcomes:
measure: Changes in NYHA functional class
timeFrame: 12 weeks and 24 weeks after the end of treatment
measure: Six-minute walking test
timeFrame: 12 weeks and 24 weeks after the end of treatment
measure: Single clinical symptoms (dyspnea, fatigue, palpitation, atypical angina and angina pectoris)
timeFrame: 12 weeks and 24 weeks after the end of treatment
measure: Quality of life
timeFrame: 12 weeks and 24 weeks after the end of treatment
measure: Left ventricular ejection fraction at rest and on exertion
timeFrame: 12 weeks after the end of treatment
measure: Regional and global wall motion, left ventricular enddiastolic diameter, and left ventricular endsystolic diameter
timeFrame: 12 weeks after the end of treatment
measure: Inflammatory state in endomyocardial biopsies
timeFrame: 12 weeks after the end of treatment
measure: Peripheral blood analyses for viral treatment effect and disease markers
timeFrame: 12 weeks after the end of treatment
measure: Composite clinical endpoint
timeFrame: 12 weeks and 24 weeks after the end of treatment
measure: Hemodynamics
timeFrame: 12 weeks after the end of treatment
Other outcomes:
Locations:
city: Nantes
country: France
city: Poitiers Cedex
country: France
city: Bad Krozingen
country: Germany
state: Baden-Württemberg
city: Ulm
country: Germany
state: Baden-Württemberg
city: München
country: Germany
state: Bayern
city: Greifswald
country: Germany
state: Mecklenburg-Vorpommern
city: Rostock
country: Germany
state: Mecklenburg-Vorpommern
city: Göttingen
country: Germany
state: Niedersachsen
city: Bad Oeynhausen
country: Germany
state: Nordrhein-Westfalen
city: Dortmund
country: Germany
state: Nordrhein-Westfalen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Köln
country: Germany
state: Nordrhein-Westfalen
city: Münster
country: Germany
state: Nordrhein-Westfalen
city: Wuppertal
country: Germany
state: Nordrhein-Westfalen
city: Ludwigshafen
country: Germany
state: Rheinland-Pfalz
city: Homburg
country: Germany
state: Saarland
city: Halle
country: Germany
state: Sachsen-Anhalt
city: Leipzig
country: Germany
state: Sachsen
city: Kiel
country: Germany
state: Schleswig-Holstein
city: Bad Berka
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Brandenburg
country: Germany
city: Hamburg
country: Germany
city: Bergamo
country: Italy
state: BG
city: Milano
country: Italy
state: MI
city: Pavia
country: Italy
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Madrid
country: Spain
city: Göteborg
country: Sweden
city: Glasgow
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: