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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
  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
Drug: Intravenous Immunoglobulins
Drug: plasma volume expander
Phase 3

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:


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 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: intravenous immunoglobulins
IV, 40 ml/kg over 4 days
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 Albuman
IV, 40 ml/kg over 4 days
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Sanquin
ClinicalTrials.gov Identifier: NCT00892112     History of Changes
Other Study ID Numbers: MD2009.01
Study First Received: May 1, 2009
Last Updated: November 18, 2014
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:
Cardiomyopathies
Cardiovascular Diseases
Heart Diseases
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Plasma Substitutes
Rho(D) Immune Globulin
Blood Substitutes
Hematologic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014