Clinical Trial: IVIg Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Biopsy Proven High PVB19 Viral Load
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Intravenous Immunoglobulin Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Biopsy Proven High PVB19 Viral Load
Brief Summary:
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).
Detailed Summary:
Sponsor: Maastricht University Medical Center
Current Primary Outcome: viral loads in EMBs before and after therapy [ Time Frame: At baseline and 6 month follow-up ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Echocardiographic analysis, NYHA functional class, type/degree of inflammation and fibrosis in the myocardium. [ Time Frame: at baseline and at 6 month follow-up ]
Original Secondary Outcome: Same as current
Information By: Maastricht University Medical Center
Dates:
Date Received: April 7, 2008
Date Started: February 2009
Date Completion: August 2010
Last Updated: February 3, 2009
Last Verified: February 2009
