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 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT06249932
Eligibility Criteria:
Inclusion Criteria:
* Age ≥20 years old
* ESRD under chronic, maintenance hemodialysis with stable dry weight for the past 6 months
* Documented left ventricular ejection fraction \<50% by any imaging modality within 1 month of screening
Exclusion Criteria:
* Age \<20 years old
* Ongoing pregnancy
* NYHA class IV heart failure
* Any hospitalization for heart failure within the past month
* Ongoing acute urinary tract infection at the time of screening
* Known acute genital infection
* Severe peripheral artery disease (Rutherford category 4-6)
* Acute coronary syndrome, stroke or transient ischemic attack within the past month
* Recent initiation of chronic maintenance hemodialysis within 6 months
* Adjustment of dry weight with changes greater than 5% of body weight within the past month
* Documented left ventricular ejection fraction ≥50% by any imaging modality within 1 month of screening
* Refused informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT06249932
Study Brief:
Protocol Section:
NCT06249932