IVIg Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Biopsy Proven High PVB19 Viral Load
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|ClinicalTrials.gov Identifier: NCT00659386|
Recruitment Status : Unknown
Verified February 2009 by Maastricht University Medical Center.
Recruitment status was: Recruiting
First Posted : April 16, 2008
Last Update Posted : February 4, 2009
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).
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Drug: Intravenous immunoglobulin therapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Intravenous Immunoglobulin Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Biopsy Proven High PVB19 Viral Load|
|Study Start Date :||February 2009|
|Estimated Primary Completion Date :||February 2010|
|Estimated Study Completion Date :||August 2010|
Patients with chronic idiopathic cardiomyopathy and EMB proven high PVB19 virus load.
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.
Other Name: IVIG
- viral loads in EMBs before and after therapy [ Time Frame: At baseline and 6 month follow-up ]
- Echocardiographic analysis, NYHA functional class, type/degree of inflammation and fibrosis in the myocardium. [ Time Frame: at baseline and at 6 month follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659386
|Contact: Robert M Dennert, MDfirstname.lastname@example.org|
|University Hospital Maastricht||Recruiting|
|Maastricht, Netherlands, 6229 HX|
|Contact: Robert Dennert email@example.com|
|Principal Investigator: Stephane Heymans, PhD, MD|
|Principal Investigator:||Stephane Heymans, MD, PhD||Maastricht University Medical Center|