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 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT06475105
Eligibility Criteria:
Inclusion Criteria:
* Agree to be included in the research by signing informed consent
* Patients with a clinical diagnosis of acute decompensated heart failure with at least one clinical sign of volume overload with a congestion score ≥2 (ADVOR Score) (e.g. edema (score 2 or more), ascites confirmed by physical examination or ultrasonography or pleural effusion confirmed by chest x-ray or echocardiography).
* Patients on routine oral loop diuretic therapy with a dose of ≥40 mg furosemide for ≥1 month
* Plasma NT-proBNP levels that increase ≥300 pg/mL or the applicable cut-off according to the age range at the time of examination in the ER.
Exclusion Criteria:
* Subjects with acute coronary syndrome
* History of congenital heart disease requiring surgical correction.
* Subjects in cardiogenic shock.
* Estimated glomerular filtration rate \<20 mL/min/1.73m² at the time of examination.
* Use of renal replacement therapy or ultrafiltration at any time before the study was included.
* Treatment with acetazolamide within 1 month before randomization.
* Exposure to nephrotoxic agents (i.e. contrast dye) is anticipated within the next 3 days
* Subjects who are pregnant or breastfeeding.
* Subjects with urinary incontinence who are unwilling to use a bladder catheter.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06475105
Study Brief:
Protocol Section:
NCT06475105