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

Information source: Sanquin
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myocardial Diseases; PVB19 Viral Load

Intervention: Intravenous Immunoglobulins (Drug); plasma volume expander (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Sanquin

Official(s) and/or principal investigator(s):
S Heymans, PhD, MD, Principal Investigator, Affiliation: AZM, Maastricht

Overall contact:
I Kleine Budde, PhD, Email: i.kleinebudde@sanquin.nl

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 Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Secondary outcome: Secondary objectives include changes in presence of cardiotrophic viruses, inflammation , fibrosis, cardiac functional capacity, patient quality of life, other echocardiographic parameters.

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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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 >115┬Ámol/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

Locations and Contacts

I Kleine Budde, PhD, Email: i.kleinebudde@sanquin.nl

AZM, Maastricht, Netherlands; Recruiting
S Heymans, PhD, MD
C GM Eurlings, MD
R Dennert, MD, Sub-Investigator
S Heymans, PhD, MD, Principal Investigator
Casper GM Eurlings, MD, Sub-Investigator
Additional Information

Starting date: November 2009
Last updated: January 10, 2013

Page last updated: February 07, 2013

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