Intravenous Immunoglobulin (IVIg) for Parvovirus B19(PVB19) Mediated Cardiomyopathy - Full Text View

Sponsor:	Sanquin
Information provided by:	Sanquin
ClinicalTrials.gov Identifier:	NCT00892112

Purpose

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.

Condition	Intervention	Phase
Myocardial Diseases PVB19 Viral Load	Drug: Intravenous Immunoglobulins Drug: plasma volume expander	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Immunoglobulin Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Parvovirus B19 Persistence - a Prospective, Double-blind, Randomized, Placebo-controlled Clinical Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Danon disease

MedlinePlus related topics: Cardiomyopathy

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by Sanquin:

Primary Outcome Measures:

The main study parameter is the change in cardiac ejection fraction presence of the heart from baseline to endpoint. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	November 2009
Estimated Study Completion Date:	November 2014
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: intravenous immunoglobulins	Drug: Intravenous Immunoglobulins 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 Name: Nanogam
Placebo Comparator: plasma volume expander G.P.O.	Drug: plasma volume expander 10 ml/kg BW will be administrated on four consecutive days. Other Name: G.P.O. ("Gepasteuriseerde Plasma-eiwit Oplossing")

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 >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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892112

Contacts

Contact: I Kleine Budde, PhD

i.kleinebudde@sanquin.nl

Locations

Netherlands
AZM	Recruiting
Maastricht, Netherlands
Contact: S Heymans, PhD, MD
Contact: C GM Eurlings, MD
Sub-Investigator: R Dennert, MD
Principal Investigator: S Heymans, PhD, MD
Sub-Investigator: Casper GM Eurlings, MD

Sponsors and Collaborators

Sanquin

Investigators

Principal Investigator:

S Heymans, PhD, MD

AZM, Maastricht

More Information

No publications provided

Responsible Party:	P.F.W. Strengers, Sanquin
ClinicalTrials.gov Identifier:	NCT00892112 History of Changes
Other Study ID Numbers:	MD2009.01
Study First Received:	May 1, 2009
Last Updated:	July 19, 2011
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Sanquin:

Immunoglobulins, Intravenous
Cardiomyopathies
Parvo B19, Human

Additional relevant MeSH terms:

Parvoviridae Infections
Cardiomyopathies
DNA Virus Infections
Virus Diseases
Heart Diseases
Cardiovascular Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous

Rho(D) Immune Globulin
Plasma Substitutes
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Blood Substitutes
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012