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 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT06414759
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients with ages ≥ 18 years old, and less than 65 years old.
* For both elective and emergency hospital admissions, patients with a clinical diagnosis of ADHF must exhibit at least one clinical sign indicative of volume overload. These signs may include edema (score 2 or higher), ascites confirmed through echography, or pleural effusion confirmed by chest X-ray or echography or rales on auscultation, or jugular venous pressure greater than10 mm Hg.
Exclusion Criteria:
* Patient diagnosed with acute kidney injury upon hospital admission based on the presence of any of the following criteria: an increase in SCr by at least 0.3 mg/dL within 48 hours, an increase in SCr to at least 2 times the baseline value, known or presumed to have occurred within the prior 7 days, and a urine volume less than 0.5 ml/kg/hour for a duration of 6 hours.
* Patients with acute pulmonary edema caused by increased afterload and fluid redistribution to the lungs in the absence or with minimal fluid accumulation.
* Anticipated exposure to nephrotoxic agents (such as contrast dye) during hospitalization.
* Patients who exhibit anuria or are undergoing renal replacement therapy or ultrafiltration.
* Patients with eGFR less than 30 mL/min/1.73m² at the time of screening.
* Expected use of intravenous inotropes, vasopressors, or nitroprusside during the study.
* Prior cardiac transplantation and/or utilization of a ventricular assist device.
* Blood pressure below 90 mmHg or mean arterial pressure below 65 mmHg at the time of recruitment.
* Patients who are pregnant or breastfeeding.
* Administration of acetazolamide or metolazone within the one-month period preceding randomization.
* The usage of any diuretic agent during the treatment phase is not specified in the study protocol, except for mineralocorticoid receptor antagonists.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06414759
Study Brief:
Protocol Section:
NCT06414759