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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00659386

Enrollment

Registered

2008-04-16

Start date

2009-02-28

Completion date

2010-08-31

Last updated

2009-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart failure, Parvovirus B19, Intravenous immuneglobulin

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).

Interventions

DRUGIntravenous 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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
viral loads in EMBs before and after therapy	At baseline and 6 month follow-up

Secondary

Measure	Time frame
Echocardiographic analysis, NYHA functional class, type/degree of inflammation and fibrosis in the myocardium.	at baseline and at 6 month follow-up

Countries

Netherlands

Contacts

Primary ContactRobert M Dennert, MD

robertdennert@cardio.azm.nl+31433875102

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026