Heart Failure Clinical Trial
Official title:
Intravenous Immunoglobulin Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Biopsy Proven High PVB19 Viral Load
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).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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