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 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
NCT ID:
NCT06111768
Eligibility Criteria:
Inclusion Criteria:
1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged ≥ 18 and ≤ 85 years-old
4. Diagnosed with heart failure of either preserved or reduced left ventricular function
5. NT-proBNP \> 300 pg/mL
6. Ability to take an oral medication
7. Willing to adhere to the SGLT2i + usual care regimen
Exclusion Criteria:
1. Current use of SGLT2 inhibitor or use in the past 72 hours
2. Pregnancy or lactation (a pregnancy test will be performed prior to enrollment in women of child-bearing age)
3. Known allergic reactions to components of an SGLT2 inhibitor
4. Treatment with another investigational drug for heart failure different from or in addition to usual care within the 72 hours preceding AKI
5. Any individual who meets any of the following criteria will be excluded from participation in this study:
* Documented history of ileal conduit (neobladder)
* No means of collecting urine such as patients with documented incontinence without indwelling or external urinary catheter
* Advanced kidney disease at baseline defined as baseline eGFR \< 25 ml/min/1.73m2
* Unexplained hypoglycemia in the past 30 days from enrollment
* History of Fournier's gangrene (pelvic necrotizing fasciitis)
* History of recurrent urinary tract infection (UTI): defined as documented UTI at least 2x in the past 6 months or 3 x in the past 12 months
* End-stage kidney disease with dialysis requirement
* Oliguria: defined as less than 30 ml urine output per hour for more than two consecutive hours or less than 500 ml over the preceding 24 hours
* Severe acute kidney injury with indications for dialysis
* Current dialysis receipt for acute kidney injury
* Comfort measures only
* Solid organ transplant on immunosuppression
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06111768
Study Brief:
Protocol Section:
NCT06111768