Intravenous Immunoglobulin (IVIg) for Parvovirus B19(PVB19) Mediated Cardiomyopathy

Myocardial Diseases Clinical Trial

Official title:
Immunoglobulin Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Parvovirus B19 Persistence - a Prospective, Double-blind, Randomized, Placebo-controlled Clinical Trial

Status Completed

Clinical Trial Summary

A prospective randomized double-blind placebo-controlled trail to investigate the effect of high doses of IVIg on cardiac functional capacity and virus presence in a subgroup of patients with chronic symptomatic ICM and a high PVB19 load in the heart.

Clinical Trial Description

Rationale: Parvovirus B19 (PVB19) persistence in the heart has been associated with progressive cardiac dysfunction and evolution to idiopathic cardiomyopathy.

Objective: A controlled trial to investigate whether high dose of intravenous immunoglobulin (IVIg) in addition to conventional heart failure therapy in patients with idiopathic cardiomyopathy and PVB19 persistence in the heart achieves improvement of cardiac function in conjunction with virus elimination.

Study design: All patients will undergo routine diagnostic work-up (including physical examination, coronary angiogram, transthoracic echocardiogram, blood studies and endomyocardial biopsies (EMB)), treatment and follow-up for their heart failure. Patients will be randomized to either receive IVIg or placebo on top of their standard heart failure regimen. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00892112
Study type	Interventional
Source	Sanquin
Contact
Status	Completed
Phase	Phase 3
Start date	November 2009
Completion date	June 2018

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