IVIg Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Biopsy Proven High PVB19 Viral Load

Maastricht University Medical Centre (MUMC)

Status and phase: Unknown; Phase 1

Conditions: Heart Failure

Treatments: Drug: Intravenous immunoglobulin therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00659386

MEC 08-4-010

Details and patient eligibility

About

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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40 participants in 1 patient group

A

Experimental group

Description:

Patients with chronic idiopathic cardiomyopathy and EMB proven high PVB19 virus load.

Treatment:

Drug: Intravenous immunoglobulin therapy