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 @ 4:26 PM
Ignite Modification Date:
2025-12-24 @ 4:26 PM
NCT ID:
NCT06783166
Eligibility Criteria:
Inclusion Criteria:
1. Adults aged 18 years or older who are hospitalized for hypervolemic AHF, with evidence of congestion defined as either:
* 2 of the following signs or symptoms: peripheral edema, ascites, jugular venous pressure \> 10mmHg, orthopnea, paroxysmal nocturnal dyspnea, 5-pound weight gain, or signs of congestion on chest x-ray or lung ultrasound. OR
* If pulmonary artery catheterization is available, a pulmonary capillary wedge pressure greater than 19 mmHg plus a systemic physical exam finding of hypervolemia from the list above.
2. Randomized within 24 hours of hospitalization for AHF.
3. Planned use of IV loop diuretic therapy during current hospitalization
4. Estimated glomerular filtration rate (eGFR) of at least 30 ml/min/1.73m2 by the MDRD equation.
Exclusion Criteria:
1. Unable to follow instructions.
2. Treated with any proximal tubular diuretics.
3. Systolic blood pressure of less than 90 mm Hg.
4. An estimated glomerular filtration rate (GFR) of less than 20 ml per 1.73 m2 of body-surface area.
5. Type 1 diabetes mellitus.
6. Dyspnea is primarily due to non-cardiac causes.
7. Cardiogenic shock.
8. Acute coronary syndrome within 30 days prior to randomization.
9. Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization.
10. Signs of ketoacidosis and/or hyperosmolar hyperglycemic syndrome (pH\>7.30 and glucose \>15 mmol/L and HCO3\>18 mmol/L).
11. Pregnant or nursing (lactating) women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06783166
Study Brief:
Protocol Section:
NCT06783166