Clinical Trial: Intravenous Immunoglobulin (IVIg) for Parvovirus B19(PVB19) Mediated Cardiomyopathy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Immunoglobulin Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Parvovirus B19 Persistence - a Prospective, Double-blind, Randomized, Placebo-control
Brief 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.
Detailed Summary:
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.
Sponsor: Sanquin
Current Primary Outcome: The main study parameter is the change in cardiac ejection fraction presence of the heart from baseline to endpoint. [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Secondary objectives include changes in presence of cardiotrophic viruses, inflammation , fibrosis, cardiac functional capacity, patient quality of life, other echocardiographic parameters. [ Time Frame: 6 months ]
Original Secondary Outcome: Same as current
Information By: Sanquin
Dates:
Date Received: May 1, 2009
Date Started: November 2009
Date Completion: March 2018
Last Updated: May 12, 2017
Last Verified: May 2017
