IVIg Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Biopsy Proven High PVB19 Viral Load
Status:
Unknown status
Trial end date:
2010-08-01
Target enrollment:
Participant gender:
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).