Using a diabetes medication to help patients with heart and kidney issues

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

This study is testing if adding a diabetes medication to standard care can help adults with heart failure and kidney problems feel better and recover faster.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Yale University (Academic / other)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT06111768 on ClinicalTrials.gov

What this trial studies

This study investigates the feasibility of adding sodium-glucose cotransporter-2 (SGLT2) inhibitors to the usual care for patients hospitalized with acute heart failure who also develop acute kidney injury. It aims to determine if this combination can improve symptoms and kidney function recovery more effectively than standard treatment alone. The study will enroll adults aged 18 to 85 with heart failure and assess various health markers to inform future larger trials. The ultimate goal is to promote the safe use of SGLT2 inhibitors in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 with diagnosed heart failure and acute kidney injury.

Not a fit: Patients currently using SGLT2 inhibitors or those with certain medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved recovery times and better management of heart failure in patients with kidney injury.

How similar studies have performed: While SGLT2 inhibitors have shown promise in heart failure management, this specific approach in acute kidney injury is novel and has not been extensively tested.

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

Where this trial is running

New Haven, Connecticut

• Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)

Study contacts

• Principal investigator: Abinet Aklilu — Yale University
• Study coordinator: Abinet Aklilu

Conditions Cardiorenal Syndrome