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 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT01758627
Eligibility Criteria:
Inclusion Criteria:
1. At least two non-planned admissions for acute heart failure (AHF), the last episode being in the past 6 months
2. New York Heart Association (NYHA) functional class III/IV and left ventricular ejection fraction (LVEF) less than 40%
3. Persistent congestion despite optimal loop diuretic therapy
4. Presence of renal dysfunction \[estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2\] documented at least once in the last 6 months
Exclusion Criteria:
1. \< 20 years of age
2. Pregnancy
3. Unsuitable for PD (patients with major abdominal wall defects)
4. Allergic to starch or other contraindication to icodextrin (5) End-stage renal disease (eGFR \< 10 ml/min/1.73 m2) requring dialysis treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01758627
Study Brief:
Protocol Section:
NCT01758627