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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00659386
• Other study ID #: MEC 08-4-010
• Status: Recruiting
• Phase: Phase 1
• First received: April 7, 2008
• Last updated: February 3, 2009
• Start date: February 2009
• Est. completion date: August 2010

Study information

• Verified date: February 2009
• Source: Maastricht University Medical Center
• Contact: Robert M Dennert, MD
• Phone: +31433875102
• Email: robertdennert[@]cardio.azm.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Netherlands	University Hospital Maastricht	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	viral loads in EMBs before and after therapy		At baseline and 6 month follow-up	No
Secondary	Echocardiographic analysis, NYHA functional class, type/degree of inflammation and fibrosis in the myocardium.		at baseline and at 6 month follow-up	No