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

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.

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Key information

Conditions

Myocardial Diseases Cardiomyopathies Cardiovascular Diseases Heart Diseases Parvovirus B19, Human

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

AZM

Maastricht, 6229 HX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Idiopathic cardiomyopathy (LVEF <45%) >6months
Optimal conventional heart failure medication >3 months.
PVB19 viral load >200 copies/mcg DNA in endomyocardial biopsies (EMBs).
Signed informed consent
Aged between 18 and 75 years

Exclusion criteria

Other causes for heart failure
Significant coronary artery disease (lesions >70 % stenosis)
Significant valvular disease
Untreated hypertension (blood pressure >140mmHg)
Substance abuse
Chemotherapy induced
Significant titer of other cardiotrophic viruses (EV, ADV, HHV6, EBV)
Pregnancy or lactation
Systemic diseases such as sarcoidosis, giant cell myocarditis, hemochromatosis, or systemic autoimmune diseases.
Treatment with any other investigational drug within 7 days before study entry or previous enrolment in this study
Known with allergic reactions against human plasma or plasma products
Having an ongoing progressive terminal disease, including HIV infection
Having renal insufficiency (plasma creatinin >115µmol/L or creatinin clearance <20 ml/min)
Having an ongoing active disease causing general symptoms e.g. chronic active hepatitis, persistent enterovirus infection with ongoing systemic complaints
Having detectable anti-IgA antibodies
Active SLE

Treatment and study plan

Intravenous immunoglobulins

Drug

2 gr/kg body weight of intravenous immunoglobulin product Nanogam® administered as 0.5 gr/kg IV over a period of 6 hours on each of 4 consecutive days

Other names: Nanogam

plasma volume expander

Drug

10 ml/kg BW will be administrated on four consecutive days.

Other names: G.P.O. ("Gepasteuriseerde Plasma-eiwit Oplossing"), Albuman 40 g/l

Primary outcomes

The main study parameter is the change in cardiac ejection fraction presence of the heart from baseline to endpoint.

Time frame: 6 months

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Prothya Biosolutions

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2018
Study completion: 2018
First posted: May 4, 2009
Registry last updated: Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed