Dapagliflozin for Heart Failure

Not yet recruiting at 1 trial location

Overseen By Francis Wilson

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Abinet Aklilu, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for hospitalized patients with heart failure who also have acute kidney injury. Participants should be stable enough to take oral medication and not require immediate dialysis. Specific criteria may exclude some individuals based on their medical history or current health status.

Inclusion Criteria

Provision of signed and dated informed consent form

I have been diagnosed with heart failure.

I am willing and available to follow the study rules for its entire duration.

Exclusion Criteria

I have had unexplained low blood sugar in the last 30 days.

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

I need dialysis for severe kidney injury.

What Are the Treatments Tested in This Trial?

Interventions

• Dapagliflozin

Trial Overview The study tests if adding a drug called Dapagliflozin, which is an SGLT2 inhibitor, to the usual care for these patients can improve outcomes like survival, need for dialysis, progression of kidney injury, fluid management, and heart failure symptoms compared to a placebo.

How Is the Trial Designed?

Group I: SGLT2i Experimental Treatment 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+