Clinical trial NCT00659386: IVIg Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Biopsy Proven High PVB19 Viral Load
Official title: Intravenous Immunoglobulin Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Biopsy Proven High PVB19 Viral Load
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Heart Failure
Keywords: Heart failure
Parvovirus B19
Intravenous immuneglobulin
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2008-04-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: viral loads in EMBs before and after therapy
timeFrame: At baseline and 6 month follow-up
Secondary outcomes:
measure: Echocardiographic analysis, NYHA functional class, type/degree of inflammation and fibrosis in the myocardium.
timeFrame: at baseline and at 6 month follow-up
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: University Hospital Maastricht
Study officials:
affiliation: Maastricht University Medical Center
name: Stephane Heymans, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.