Recruiting
Phase 2

SGLT2 Inhibitors

Sponsor:

Yale University

Code:

NCT07273838

Conditions

Heart Failure

Acute Kidney Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Dapagliflozin 10mg Tab

Placebo

Study Details

Brief summary:

The overall objective of this study is to determine whether the addition of SGLT2 inhibitors to usual care in hospitalized patients with heart failure associated acute kidney injury is safe and efficacious. Investigators will assess if SGLT2 inhibition improves a composite cardio-renal outcome (mortality, dialysis, AKI progression, decongestion metrics, heart failure symptoms). Secondary objectives of this study are to compare individual components of the composite outcome as well as changes in biomarkers of kidney injury, inflammation, repair and oxidative stress between those exposed to the SGLT2 inhibitor vs placebo.

Conditions

Heart Failure

Acute Kidney Injury

Study ID

NCT07273838

Start date

Mar 5, 2026

Status verified date

Mar, 2026

Completion date

Oct 31, 2029

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SGLT2i

Subjects receive once daily 10 mg of oral dapagliflozin (Farxiga) for 14 days (or until discharge). Empaglifolozin may be used in case of dapagliflozin shortage.

placebo comparator: Placebo

Subjects receive once daily administration of a placebo comparator for 14 days (or until discharge).

Interventions

Dapagliflozin 10mg Tab

Administration of 10mg oral dapagliflozin once daily for 14 days (or until discharge).

Placebo

Administration of placebo comparator once daily for 14 days (or until discharge).

Primary outcome measure

  • Cardio-renal clinical improvement calculated as a Win Ratio [ Time Frame: Calculated at 30 days post-randomization ]

Central Contacts and Locations

Central contacts

Abinet Aklilu, MD

203-931-5064abinet.aklilu@yale.edu

Francis Wilson

francis.p.wilson@yale.edu

Locations

Yale New Haven Hospital-St. Raphael Campus

Recruiting

New Haven, Connecticut, United States, 06510

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

More Information

Sponsor

Yale University

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Keywords

  • Acute cardiorenal syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Yale University on 2026-03-13.