Using the SGLT2 pill dapagliflozin for hospitalized adults with heart failure who develop acute kidney injury.
Sodium-Glucose Cotransporter-2 Inhibitor for Amelioration of Acute Cardiorenal Syndrome: A Randomized Controlled Trial
This trial will test whether adding the SGLT2 pill dapagliflozin to usual care helps hospitalized adults with heart failure who develop acute kidney injury.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Trial ID | NCT07273838 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled Phase 2 trial will enroll about 130 hospitalized adults with heart failure and concurrent acute kidney injury to receive dapagliflozin 10 mg or placebo in addition to usual care. The primary outcome is a composite cardio-renal endpoint including death, need for dialysis, progression of AKI, measures of decongestion, and changes in heart failure symptoms. Secondary outcomes include the individual components of the composite and changes in biomarkers of kidney injury, inflammation, repair, and oxidative stress. The trial is conducted at Yale New Haven Hospital sites and excludes patients with alternative explanations for AKI, current recent SGLT2i exposure, or other safety contraindications.
Who should consider this trial
Good fit: Hospitalized adults aged 18–85 with heart failure (reduced or preserved ejection fraction), signs of heart failure exacerbation, and recent acute kidney injury who can take oral medication and consent to participate.
Not a fit: Patients whose AKI is clearly due to another cause, those already on an SGLT2 inhibitor, pregnant or breastfeeding people, or those with contraindications to SGLT2 inhibitors are unlikely to benefit.
Why it matters
Potential benefit: If successful, the treatment could allow safer continuation of heart failure medicines, speed decongestion, and reduce progression to dialysis or death in patients with acute cardiorenal syndrome.
How similar studies have performed: Large trials have shown SGLT2 inhibitors reduce heart failure hospitalizations and slow chronic kidney disease, but their safety and benefit specifically in hospitalized patients with acute cardiorenal syndrome and AKI remain relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged ≥ 18 and ≤ 85 years-old * Diagnosed with heart failure of either preserved or reduced left ventricular function * Have signs of heart failure exacerbation * Ability to take an oral medication * Willing to adhere to the SGLT2i vs placebo regimen Exclusion Criteria: * AKI can be primarily explained by another etiology * Current use of SGLT2 inhibitor or exposure in the past 72 hours * Pregnancy or lactation (pregnancy test prior to enrollment in women of child-bearing age) * Known allergic reactions to components of an SGLT2 inhibitor * Treatment with another investigational drug for heart failure different from or in addition to usual care within the 72 hours preceding AKI * 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 preceding 6 months or 3 x in the preceding 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 and 1 other locations
- Yale New Haven Hospital-St. Raphael Campus — New Haven, Connecticut, United States (Recruiting)
- Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Abinet Aklilu, MD — Yale University
- Study coordinator: Abinet Aklilu, MD
- Email: abinet.aklilu@yale.edu
- Phone: 203-931-5064
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.