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

Immunoglobulin therapy for patients with idiopathic cardiomyopathy and endomyocardial parvovirus B19 persistence - a prospective, double-blind, randomized, placebo-controlled clinical trial - IVIg for PVB19 mediated cardiomyopathy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33416

Enrollment

Registered

2009-03-23

Start date

2009-10-30

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

viral mediated heartfailure

Interventions

Intervention: Patients will be randomised into 2 groups. Both groups will continue with their regular heart failure regimen. Group A will receive a total dose of 2 gr/kg bodyweight of intravenous im

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Symptomatic idiopathic cardiomyopathy >6 months * Optimal conventional heart failure medication >200 copies/mcg DNA in endomyocardial biopsies * Signed informed consent * Age between 18 and 75 years

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The main study parameter is the change in cardiac ejection fraction presence of the heart from baseline to endpoint.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)