Sodium-Glucose Cotransporter-2 Inhibitor for Acute Cardiorenal Syndrome: A Feasibility Study

Launched by YALE UNIVERSITY · Oct 26, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called SGLT2 inhibitors to see if it can help patients with acute heart failure who also have kidney problems. The goal is to find out if adding this medication to standard treatments can help patients feel better and recover kidney function faster. The study is currently recruiting participants who are adults aged 18 to 85, diagnosed with heart failure, and able to take oral medications.

To be eligible for the trial, participants must be willing to follow the study procedures and provide consent. However, those currently using SGLT2 inhibitors, pregnant or breastfeeding women, and individuals with certain medical conditions or treatments will not be able to join. Participants can expect to receive standard care for their heart failure along with the SGLT2 medication, and the study will help researchers understand if this approach is acceptable and feasible for future larger trials.

Gender

ALL

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