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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00892112
Recruitment Status : Recruiting
First Posted : May 4, 2009
Last Update Posted : April 19, 2018
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Myocardial Diseases Parvovirus B19, Human Drug: Intravenous Immunoglobulins Drug: plasma volume expander Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : November 2009
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arm Intervention/treatment
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 Names:
  • G.P.O. ("Gepasteuriseerde Plasma-eiwit Oplossing")
  • Albuman 40 g/l

Primary Outcome Measures :
  1. The main study parameter is the change in cardiac ejection fraction presence of the heart from baseline to endpoint. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00892112

Contact: I Kleine Budde, PhD

AZM Recruiting
Maastricht, Netherlands, 6229 HX
Contact: S Heymans, PhD, MD         
Contact: M Hazebroek, MD         
Sub-Investigator: R Dennert, MD         
Principal Investigator: S Heymans, PhD, MD         
Sub-Investigator: Casper GM Eurlings, MD         
Sub-Investigator: Mark Hazebroek, MD         
Sub-Investigator: Jort Merken, MD         
Sponsors and Collaborators
Principal Investigator: S Heymans, PhD, MD AZM, Maastricht

Responsible Party: Sanquin Identifier: NCT00892112     History of Changes
Other Study ID Numbers: MD2009.01
First Posted: May 4, 2009    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018

Keywords provided by Sanquin:
Immunoglobulins, Intravenous
Parvo B19, Human

Additional relevant MeSH terms:
Parvoviridae Infections
Heart Diseases
Cardiovascular Diseases
DNA Virus Infections
Virus Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Plasma Substitutes
Immunologic Factors
Physiological Effects of Drugs
Blood Substitutes