Sodium-Glucose Cotransporter-2 Inhibitor for Patients With Acute Cardiorenal Syndrome

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07273838
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Dapagliflozin 10mg Tab — DRUG
    Administration of 10mg oral dapagliflozin once daily for 14 days (or until discharge).
  • Placebo — DRUG
    Administration of placebo comparator once daily for 14 days (or until discharge).

Study Details

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.

Key Dates

Start date
Mar 5, 2026
Status verified
Mar 2026
Primary completion
Aug 31, 2028
Completion
Oct 31, 2029

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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).

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yale New Haven HospitalNew HavenConnecticut06510
Abinet Aklilu, MD
Yale New Haven Hospital-St. Raphael CampusNew HavenConnecticut06510
Abinet Aklilu, MD

Find similar trials in New Haven, CT

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Yale New Haven Hospital· New Haven, CTYale New Haven Hospital-St. Raphael Campus· New Haven, CT

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