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

Phase 3

Completed

• Conditions: Myocardial Diseases; Parvovirus B19, Human
• Interventions: Drug: Intravenous Immunoglobulins; Drug: plasma volume expander

• Registration Number: NCT00892112
• Lead Sponsor: Prothya Biosolutions

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 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 Timeline

• Study First Submitted: 2009-05-01
• Study First Submitted QC: 2009-05-01
• Study First Posted: 2009-05-04
• Study Start: 2009-11
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravenous immunoglobulins	Intravenous Immunoglobulins	IV, 40 ml/kg over 4 days
plasma volume expander Albuman	plasma volume expander	IV, 40 ml/kg over 4 days

Primary Outcome Measures

Name	Time	Method
The main study parameter is the change in cardiac ejection fraction presence of the heart from baseline to endpoint.	6 months

Secondary Outcome Measures

Name	Time	Method
Secondary objectives include changes in presence of cardiotrophic viruses, inflammation , fibrosis, cardiac functional capacity, patient quality of life, other echocardiographic parameters.	6 months

Trial Locations

Locations (1)

AZM; 🇳🇱 Maastricht, Netherlands