Heart Failure Clinical Trials

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Sodium-Glucose Cotransporter-2 Inhibitor for Amelioration of Acute Cardiorenal Syndrome: A Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: t
View:

• 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

Locations
United States
Connecticut
Yale New Haven Hospital
RECRUITING
New Haven
Yale New Haven Hospital-St. Raphael Campus
RECRUITING
New Haven
Contact Information
Primary
Abinet Aklilu, MD
abinet.aklilu@yale.edu
203-931-5064
Backup
Francis Wilson
francis.p.wilson@yale.edu
Time Frame
Start Date: 2026-03-05
Estimated Completion Date: 2029-10-31
Participants
Target number of participants: 130
Treatments
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).
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Yale University

This content was sourced from clinicaltrials.gov