DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Maastricht University Medical Center
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heart Failure

Intervention: Intravenous immunoglobulin therapy (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Maastricht University Medical Center

Official(s) and/or principal investigator(s):
Stephane Heymans, MD, PhD, Principal Investigator, Affiliation: Maastricht University Medical Center

Overall contact:
Robert M Dennert, MD, Phone: +31433875102, Email: robertdennert@cardio.azm.nl

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).

Clinical Details

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

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

Primary outcome: viral loads in EMBs before and after therapy

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Robert M Dennert, MD, Phone: +31433875102, Email: robertdennert@cardio.azm.nl

University Hospital Maastricht, Maastricht 6229 HX, Netherlands; Recruiting
Robert Dennert, Email: robertdennert@cardio.azm.nl
Stephane Heymans, PhD, MD, Principal Investigator
Additional Information

Starting date: February 2009
Last updated: February 3, 2009

Page last updated: December 08, 2011

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014