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

Phase 1

• Conditions: Heart Failure
• Interventions: Drug: Intravenous immunoglobulin therapy

• Registration Number: NCT00659386
• Lead Sponsor: Maastricht University Medical Center

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 Description

Not available

Study Timeline

• Study First Submitted: 2008-04-07
• Study First Submitted QC: 2008-04-14
• Study First Posted: 2008-04-16
• Status Verified: 2009-02
• Study Start: 2009-02
• Last Update Submitted: 2009-02-03
• Last Update Posted: 2009-02-04
• Primary Completion: 2010-02
• Study Completion: 2010-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Intravenous immunoglobulin therapy	Patients with chronic idiopathic cardiomyopathy and EMB proven high PVB19 virus load.

Primary Outcome Measures

Name	Time	Method
viral loads in EMBs before and after therapy	At baseline and 6 month follow-up

Secondary Outcome Measures

Name	Time	Method
Echocardiographic analysis, NYHA functional class, type/degree of inflammation and fibrosis in the myocardium.	at baseline and at 6 month follow-up

Trial Locations

Locations (1)

University Hospital Maastricht; 🇳🇱 Maastricht, Netherlands