IVIg Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Biopsy Proven High PVB19 Viral Load
Recruitment status was Recruiting
Rationale: Parvovirus B19 (PVB19) persistence in the heart has been associated with progressive cardiac dysfunction and evolution to dilated cardiomyopathy.
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Intravenous Immunoglobulin Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Biopsy Proven High PVB19 Viral Load|
- viral loads in EMBs before and after therapy [ Time Frame: At baseline and 6 month follow-up ] [ Designated as safety issue: No ]
- Echocardiographic analysis, NYHA functional class, type/degree of inflammation and fibrosis in the myocardium. [ Time Frame: at baseline and at 6 month follow-up ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||August 2010|
|Estimated Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Patients with chronic idiopathic cardiomyopathy and EMB proven high PVB19 virus load.
Drug: 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 Name: IVIG
Please refer to this study by its ClinicalTrials.gov identifier: NCT00659386
|Contact: Robert M Dennert, MDfirstname.lastname@example.org|
|University Hospital Maastricht||Recruiting|
|Maastricht, Netherlands, 6229 HX|
|Contact: Robert Dennert email@example.com|
|Principal Investigator: Stephane Heymans, PhD, MD|
|Principal Investigator:||Stephane Heymans, MD, PhD||Maastricht University Medical Center|