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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Patients with chronic idiopathic cardiomyopathy and EMB proven high PVB19 virus load. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous immunoglobulin therapy | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| viral loads in EMBs before and after therapy | At baseline and 6 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Echocardiographic analysis, NYHA functional class, type/degree of inflammation and fibrosis in the myocardium. | at baseline and at 6 month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert M Dennert, MD | Contact | +31433875102 | robertdennert@cardio.azm.nl |
| Name | Affiliation | Role |
|---|---|---|
| Stephane Heymans, MD, PhD | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Maastricht | Recruiting | Maastricht | Maastricht | 6229 HX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20386074 | Derived | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005719 | gamma-Globulins |
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
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|
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |