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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT04803968
Eligibility Criteria:
Inclusion Criteria:
* Patients with a diagnosis of heart failure in the New York Heart Association (NYHA) class II-III, who have had at least 3 months past ICD implantation, and who did not have any complications at the last pacemaker control,
* Ejection fraction (EF) value ≤45%,
* The medicines used have not been changed for at least 3 months,
* Volunteering to participate in the research, being able to attend a 1-hour rehabilitation program every day of the week,
* To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes),
* Not having any orthopedic problems that may prevent him from exercising with his bicycle and arm ergometer,
* CPET, ambulatory blood pressure and rhythm monitoring, ECG and ECHO without any obstacle to exercise within the framework of TKD cardiology guidelines (such as moderate valve disease, hypertrophic cardiomyopathy, severe uncontrolled HT…).
Exclusion Criteria:
* Those with a history of shoulder injury (severe pain around the shoulder and inability to move, severe swelling around the shoulder, shoulder dislocation)
* Those with a history of shoulder surgery,
* Sequelae of a cerebrovascular accident with mastectomy or arm involvement on the affected side,
* Having decompensated heart failure,
* Having an obstacle to exercise within the framework of TSC (Turkish Society of Cardiology) cardiology guidelines in CPET, ambulatory blood pressure and rhythm monitoring, ECG and ECO (such as moderate valve disease, hypertrophic cardiomyopathy, severe uncontrolled HT ...)
* Having a history of ICD shock in the last 6 months,
* Having an active treated malignancy or a collagen tissue disease receiving systemic steroids
* Being unable to cooperate or adapt to exercise due to cerebrovascular disease or other reasons,
* Having a chronic kidney disease undergoing dialysis where the volume load is not stable.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04803968
Study Brief:
Protocol Section:
NCT04803968