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:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT00541268
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years of age at the time of screening.
* Documented non-ischemic HF with an LVEF ≤ 35%.
* NYHA class II-III. If patients are planned for an implantation with a biventricular pacemaker NYHA class IV patients will be accepted for the trial.
* Before any study-specific procedure, including assessments for screening, the appropriate written informed consent must be obtained (see section 12.1).
* NT-proBNP above 200 pg/ml (see appendix D).
Exclusion Criteria:
To be eligible for this study, subjects must not meet any of the following criteria:
* Uncorrected congenital heart disease or valve obstruction, obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism, adrenal insufficiency, active vasculitis due to collagen vascular disease.
* On the urgent waiting list for a heart transplant (UNOS category 1A or 1B, or equivalent). Patients on the non-urgent waiting list for a heart transplant (UNOS category 2 or 7, or equivalent) are eligible for inclusion in the study.
* Recipient of any major organ transplant (eg, lung, liver, heart or kidney).
* Receiving or has received cytotoxic or cytostatic chemotherapy and/or radiation therapy for treatment of a malignancy within 6 month before randomisation or clinical evidence of current malignancy, with the following exceptions: basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, prostate cancer (if stable localized disease, with a life expectancy of \> 2.5 years in the opinion of the investigator).
* Known to be human immunodeficiency virus positive with an expected survival of less than 5 years due to HIV.
* Renal failure treated with dialysis.
* Recent (within 3 months) history of alcohol or illicit drug abuse disorder, based on self-report
* Any condition (eg, psychiatric illness) or situation that, in the investigator's opinion, could put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
* Unwilling to participate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00541268
Study Brief:
Protocol Section:
NCT00541268