IVIg Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Biopsy Proven High PVB19 Viral Load
Information source: Maastricht University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
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
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