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

Primary Purpose

Heart Failure

Status

Unknown status

Phase

Phase 1

Locations

Netherlands

Study Type

Interventional

Intervention

Intravenous immunoglobulin therapy

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Parvovirus B19, Intravenous immuneglobulin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University Hospital MaastrichtRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

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

Outcomes

Primary Outcome Measures

viral loads in EMBs before and after therapy

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00659386

First Posted

April 7, 2008

Last Updated

February 3, 2009

Sponsor

Maastricht University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00659386

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Unknown status

Study Start Date

February 2009 (undefined)

Primary Completion Date

February 2010 (Anticipated)

Study Completion Date

August 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Maastricht University Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

Heart failure, Parvovirus B19, Intravenous immuneglobulin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Intravenous immunoglobulin therapy

Other Intervention Name(s)

IVIG

Intervention Description

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.

Primary Outcome Measure Information:

Title

viral loads in EMBs before and after therapy

Time Frame

At baseline and 6 month follow-up

Secondary Outcome Measure Information:

Title

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

Time Frame

at baseline and at 6 month follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Robert M Dennert, MD

Phone

+31433875102

robertdennert@cardio.azm.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephane Heymans, MD, PhD

Organizational Affiliation

Maastricht University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Maastricht

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Dennert

robertdennert@cardio.azm.nl

First Name & Middle Initial & Last Name & Degree

Stephane Heymans, PhD, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

20386074

Citation

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.

Results Reference

derived

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

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