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

NCT00659386 | Unknown Phase 1

• 1 other identifier: MEC 08-4-010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Heart Failure

Keywords

Heart failure; Parvovirus B19; Intravenous immuneglobulin

Outcome Measures

Primary Outcomes (1)

• viral loads in EMBs before and after therapy

  At baseline and 6 month follow-up

Secondary Outcomes (1)

• Echocardiographic analysis, NYHA functional class, type/degree of inflammation and fibrosis in the myocardium.

  at baseline and at 6 month follow-up

Study Arms (1)

A

EXPERIMENTAL

Patients with chronic idiopathic cardiomyopathy and EMB proven high PVB19 virus load.

Drug: Intravenous immunoglobulin therapy

Interventions

Intravenous immunoglobulin therapy DRUG

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.

Also known as: IVIG

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

University Hospital Maastricht

Maastricht, Maastricht, 6229 HX, Netherlands

RECRUITING

Related Publications (1)

• Dennert R, Velthuis S, Schalla S, Eurlings L, van Suylen RJ, van Paassen P, Tervaert JW, Wolffs P, Goossens VJ, Bruggeman C, Waltenberger J, Crijns HJ, Heymans S. Intravenous immunoglobulin therapy for patients with idiopathic cardiomyopathy and endomyocardial biopsy-proven high PVB19 viral load. Antivir Ther. 2010;15(2):193-201. doi: 10.3851/IMP1516.

  PMID: 20386074 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

gamma-Globulins; Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin G; Immunoglobulin Isotypes; Antibodies

Study Officials

• Stephane Heymans, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert M Dennert, MD

CONTACT

+31433875102; robertdennert@cardio.azm.nl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 7, 2008
• First Posted: April 16, 2008
• Study Start: February 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: August 1, 2010
• Last Updated: February 4, 2009

Record last verified: 2009-02

Locations

NL (1)