Immunoglobulin therapy for patients with idiopathic cardiomyopathy and endomyocardial parvovirus B19 persistence - a prospective, double-blind, randomized, placebo-controlled clinical trial

Phase 3

Completed

Conditions: 10028593
viral mediated heartfailure
10047438

Registration Number: NL-OMON33416

Lead Sponsor: Sanquin Plasmaproducten

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

* Symptomatic idiopathic cardiomyopathy >6 months
* Optimal conventional heart failure medication ><=3 months
* PVB19 viral load >200 copies/mcg DNA in endomyocardial biopsies
* Signed informed consent
* Age between 18 and 75 years

Exclusion Criteria

* Other causes for heart failure:
o Significant coronary artery disease (lesions >70 % stenosis).
o Significant valvular disease
o Untreated hypertension (blood pressure >140mmHg)
o Substance abuse
o Chemotherapy induced
*Significant titer of other cardiotrophic viruses (EV, ADV, HHV6, EBV)
*Pregnancy or lactation
* Systemic diseases such as sarcoidosis, giant cell myocarditis, hemochromatosis, or systemic autoimmune diseases.
* Treatment with any other investigational drug within 7 days before study entry or previous enrolment in this study
* Known with allergic reactions against human plasma or plasma products
* Having an ongoing progressive terminal disease, including HIV infection
* Having renal insufficiency (plasma creatinin >115µmol/L or creatinin clearance <20 ml/min)
* Having an ongoing active disease causing general symptoms e.g. chronic active hepatitis, persistent enterovirus infection with ongoing systemic complaints.
* Having detectable anti-IgA antibodies
* Active SLE

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the change in cardiac ejection fraction presence of<br /><br>the heart from baseline to endpoint. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters include changes in presence of cardiotrophic viruses (per<br /><br>µg DNA of PVB19, HHV-6, EV, ADV, EBV), inflammation (CD45-staining lymphocytes<br /><br>per/mm2), fibrosis (collageen volume fractie /mm2), cardiac functional capacity<br /><br>(NYHA functional class), patient quality of life (Minnesota Living with Heart<br /><br>Failure Questionnaire), other echocardiographic parameters (LVEDD, LVESD).<br /><br>Tertiary parameters: The change in antibodies titers against Parvovirus B19<br /><br>antigens VP1/VP2 and NS1 (non-structural protein). These antibodies will be<br /><br>compared to the antibodies present in the used Nanogam batches and associated<br /><br>with changes in the presence of specific PVB19 subtypes.</p><br>