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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT02769351
Eligibility Criteria:
Inclusion Criteria:
* ≥18 years
* Inpatient-treated patients with acute volume overload, preferably in association with cardiac decompensation with signs of incipient diuretic resistance (lack of increase in urine output despite significant escalation of diuretic therapy; e.g. ≥80 mg furosemide / 24 h or less than 1375 mL urine output/40 mg furosemide per 24 h or equivalent dose of other loop diuretics \[established clinically or from the medical history\])
* New York Association Functional Class (NYHA) III-IV at inclusion
* Systolic or diastolic cardiac dysfunction (HF-REF or HF-PEF)
* Adequate venous access (preferably peripheral arm vein) allowing a flow rate ≥ 60 mL / min
* Written consent to the use of data in the registry (where necessary, by a legal guardian).
Exclusion Criteria:
* Contraindication to anticoagulation (e.g. known heparin-induced thrombocytopenia, severe bleeding)
* Terminal renal failure (stage V, GFR \<15 mL)
* Cardiogenic shock, e.g. in association with acute coronary syndrome (ACS)
* Other diseases or factors that, in the study doctor's opinion, constitute a potential contraindication to ultrafiltration
* Pregnant women, women in labour, breast-feeding women or women of childbearing potential, who are without adequate contraception or are planning a family. NB: a pregnancy test is performed systematically in women of childbearing age and the patient is not included in the event of pregnancy (positive test). It is absolutely essential that women, who have a negative test and who are included in the study, have an effective contraception.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02769351
Study Brief:
Protocol Section:
NCT02769351