IVIg Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Biopsy Proven High PVB19 Viral Load
NCT ID: NCT00659386
Last Updated: 2009-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
40 participants
INTERVENTIONAL
2009-02-28
2010-08-31
Brief Summary
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Objective: Whether high dose of intravenous immunoglobulin (IVIg) in addition to conventional heart failure therapy achieves virus reduction, thereby resulting in improvement of cardiac function.
Study design: A interventional study of virus presence and cardiac functional capacity before and after IVIg therapy.
Study population: Patients with idiopathic cardiomyopathy and symptomatic heart failure for more than 1 year and a significant PVB19 viral load in endomyocardial biopsies (EMB) and treated with high dose of IVIg were included.
Intervention (if applicable): Patients were treated with a total dose of 2 g/kg of immune globulin administered as 0.5 g/kg IV over a period of 6 hours on each of 4 consecutive days.
Main study parameters/endpoints: EMBs: virus (PVB19, enteroviruses, adenoviruses, Epstein-Barr virus, human herpes virus-6 and cytomegalovirus), inflammation (lymphocytes an macrophages) and fibrosis. Cardiac functional capacity: NYHA classification, echocardiographic evaluation (left ventricular ejection fraction, end-systolic diameter, end-diastolic diameter).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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A
Patients with chronic idiopathic cardiomyopathy and EMB proven high PVB19 virus load.
Intravenous immunoglobulin therapy
Patients received total dose of 2 g/kg of immune globulin administered as 0.5 g/kg IV over a period of 6 hours on each of 3 consecutive days.
Interventions
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Intravenous immunoglobulin therapy
Patients received total dose of 2 g/kg of immune globulin administered as 0.5 g/kg IV over a period of 6 hours on each of 3 consecutive days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Optimal conventional heart failure medication \<6 months.
* PVB19 viral load \>150copies/mcg DNA in EMBs.
Exclusion Criteria
* significant valvular disease.
* systemic diseases such as sarcoidosis, giant cell myocarditis, hemochromatosis, or systemic autoimmune diseases.
18 Years
ALL
No
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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Maastricht UMC+
Principal Investigators
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Stephane Heymans, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Locations
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University Hospital Maastricht
Maastricht, Maastricht, Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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Dennert R, Velthuis S, Schalla S, Eurlings L, van Suylen RJ, van Paassen P, Tervaert JW, Wolffs P, Goossens VJ, Bruggeman C, Waltenberger J, Crijns HJ, Heymans S. Intravenous immunoglobulin therapy for patients with idiopathic cardiomyopathy and endomyocardial biopsy-proven high PVB19 viral load. Antivir Ther. 2010;15(2):193-201. doi: 10.3851/IMP1516.
Other Identifiers
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MEC 08-4-010
Identifier Type: -
Identifier Source: org_study_id
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