Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT00892112
Eligibility Criteria:
Inclusion Criteria:
* Idiopathic cardiomyopathy (LVEF \<45%) \>6months
* Optimal conventional heart failure medication \>3 months.
* PVB19 viral load \>200 copies/mcg DNA in endomyocardial biopsies (EMBs).
* Signed informed consent
* Aged between 18 and 75 years
Exclusion Criteria:
* Other causes for heart failure
* Significant coronary artery disease (lesions \>70 % stenosis)
* Significant valvular disease
* Untreated hypertension (blood pressure \>140mmHg)
* Substance abuse
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00892112
Study Brief:
Protocol Section:
NCT00892112