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IVIg Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Biopsy Proven High PVB19 Viral Load

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Maastricht University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00659386
First received: April 7, 2008
Last updated: February 3, 2009
Last verified: February 2009
  Purpose

Rationale: Parvovirus B19 (PVB19) persistence in the heart has been associated with progressive cardiac dysfunction and evolution to dilated cardiomyopathy.

Objective: Whether high dose of intravenous immunoglobulin (IVIg) in addition to conventional heart failure therapy achieves virus reduction, thereby resulting in improvement of cardiac function.

Study design: A interventional study of virus presence and cardiac functional capacity before and after IVIg therapy.

Study population: Patients with idiopathic cardiomyopathy and symptomatic heart failure for more than 1 year and a significant PVB19 viral load in endomyocardial biopsies (EMB) and treated with high dose of IVIg were included.

Intervention (if applicable): Patients were treated with a total dose of 2 g/kg of immune globulin administered as 0.5 g/kg IV over a period of 6 hours on each of 4 consecutive days.

Main study parameters/endpoints: EMBs: virus (PVB19, enteroviruses, adenoviruses, Epstein-Barr virus, human herpes virus-6 and cytomegalovirus), inflammation (lymphocytes an macrophages) and fibrosis. Cardiac functional capacity: NYHA classification, echocardiographic evaluation (left ventricular ejection fraction, end-systolic diameter, end-diastolic diameter).


Condition Intervention Phase
Heart Failure
Drug: Intravenous immunoglobulin therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Intravenous Immunoglobulin Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Biopsy Proven High PVB19 Viral Load

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • viral loads in EMBs before and after therapy [ Time Frame: At baseline and 6 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Echocardiographic analysis, NYHA functional class, type/degree of inflammation and fibrosis in the myocardium. [ Time Frame: at baseline and at 6 month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2009
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Patients with chronic idiopathic cardiomyopathy and EMB proven high PVB19 virus load.
Drug: Intravenous immunoglobulin therapy
Patients received total dose of 2 g/kg of immune globulin administered as 0.5 g/kg IV over a period of 6 hours on each of 3 consecutive days.
Other Name: IVIG

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic heart failure <1 year.
  • Optimal conventional heart failure medication <6 months.
  • PVB19 viral load >150copies/mcg DNA in EMBs.

Exclusion Criteria:

  • significant (lesions >50% stenosis) coronary artery disease.
  • significant valvular disease.
  • systemic diseases such as sarcoidosis, giant cell myocarditis, hemochromatosis, or systemic autoimmune diseases.
  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: NCT00659386

Contacts
Contact: Robert M Dennert, MD +31433875102 robertdennert@cardio.azm.nl

Locations
Netherlands
University Hospital Maastricht Recruiting
Maastricht, Netherlands, 6229 HX
Contact: Robert Dennert       robertdennert@cardio.azm.nl   
Principal Investigator: Stephane Heymans, PhD, MD         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Stephane Heymans, MD, PhD Maastricht University Medical Center
  More Information

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: S. Heymans, Maastricht UMC+
ClinicalTrials.gov Identifier: NCT00659386     History of Changes
Other Study ID Numbers: MEC 08-4-010
Study First Received: April 7, 2008
Last Updated: February 3, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Heart failure
Parvovirus B19
Intravenous immuneglobulin

Additional relevant MeSH terms:
Cardiomyopathies
Heart Failure
Cardiovascular Diseases
Heart Diseases
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 23, 2014