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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Sanquin
Sponsor:
Information provided by (Responsible Party):
Sanquin
ClinicalTrials.gov Identifier:
NCT00892112
First received: May 1, 2009
Last updated: November 18, 2014
Last verified: January 2013

May 1, 2009
November 18, 2014
November 2009
November 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00892112 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Intravenous Immunoglobulin (IVIg) for Parvovirus B19(PVB19) Mediated Cardiomyopathy
Immunoglobulin Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Parvovirus B19 Persistence - a Prospective, Double-blind, Randomized, Placebo-controlled Clinical Trial

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Myocardial Diseases
  • PVB19
  • 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
  • Drug: plasma volume expander
    10 ml/kg BW will be administrated on four consecutive days.
    Other Name: G.P.O. ("Gepasteuriseerde Plasma-eiwit Oplossing")
  • Active Comparator: intravenous immunoglobulins
    IV, 40 ml/kg over 4 days
    Intervention: Drug: Intravenous Immunoglobulins
  • Placebo Comparator: plasma volume expander Albuman
    IV, 40 ml/kg over 4 days
    Intervention: Drug: plasma volume expander
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
November 2016
November 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: I Kleine Budde, PhD i.kleinebudde@sanquin.nl
Netherlands
 
NCT00892112
MD2009.01
No
Sanquin
Sanquin
Not Provided
Principal Investigator: S Heymans, PhD, MD AZM, Maastricht
Sanquin
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP