Overview

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:
0
Participant gender:
All
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).
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Maastricht University Medical Center
Treatments:
Antibodies
gamma-Globulins
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Criteria
Inclusion Criteria:

- Idiopathic heart failure <1 year.

- Optimal conventional heart failure medication <6 months.

- PVB19 viral load >150copies/mcg DNA in EMBs.

Exclusion Criteria:

- significant (lesions >50% stenosis) coronary artery disease.

- significant valvular disease.

- systemic diseases such as sarcoidosis, giant cell myocarditis, hemochromatosis, or
systemic autoimmune diseases.