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:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT04139460
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years of age at the time of screening
* Documented non-ischemic HF with an LVEF ≤ 35
* QRS≥130ms; NYHA class II-IV
* Signed written informed consent
* NT-proBNP above 200 pg/ml
Exclusion 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
* Presence 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 (e.g., lung, liver, heart)
* Receiving or has received cytotoxic or cytostatic chemotherapy and/or radiation therapy for treatment of a malignancy within 6 month before randomization 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
* Chronic kidney disease with glomerular filtration rate \<30 ml/min
* Chronic dialysis treatment
* Recent (within 3 months) history of alcohol or illicit drug abuse disorder, based on self-report
* Any condition (e.g., 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
Additional information related to inclusion and exclusion criteria:
* The qualifying LVEF and NT-proBNP level has to be measured after a maximal tolerated pharmacotherapy of heart failure has been achieved.
* A non-ischemic cause of HF has to be determined by coronary angiography. Patients could be included even if they will have one or two coronary arteries with stenosis, if the extent of coronary artery disease will not be considered to be sufficient to account for the reduced LVEF. Patients with a significant coronary heart disease (CAD) will be excluded.
* Patients with an existing conventional pacemaker could be included if they will be willing to have the device changed or upgraded.
* Patients with any form of atrial fibrillation will not be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT04139460
Study Brief:
Protocol Section:
NCT04139460