Active — Not RecruitingPhase 2

Sodium-Glucose Cotransporter-2 Inhibitor for Acute Cardiorenal Syndrome: A Feasibility Study

United States30 participantsStarted 2024-05-30

Plain-language summary

The long-term objective of this study is to test whether the addition of SGLT2 inhibitors to usual care during acute heart failure management in patients who develop kidney injury shortens the time to achieving symptomatic improvement and kidney function recovery. The study aims to assess feasibility and acceptability of such a randomized clinical trial.

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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
✓. NT-proBNP \> 300 pg/mL
✓. Ability to take an oral medication
✓. Willing to adhere to the SGLT2i + usual care regimen

Exclusion criteria

✕. Current use of SGLT2 inhibitor or use in the past 72 hours
✕. Pregnancy or lactation (a pregnancy test will be performed 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:

What they're measuring

Percentage of eligible versus consented patients

Timeframe: From study initiation to study close (about 2 years)

Percentage of enrolled patients with completed sample collections

Timeframe: From study initiation to study close (about 2 years)

Enrollment rate

Timeframe: From study initiation to study close (about 2 years)

Trial details

NCT IDNCT06111768

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

View on ClinicalTrials.gov More Cardiorenal Syndrome trials

Plain-language summary

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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
✓. NT-proBNP \> 300 pg/mL
✓. Ability to take an oral medication
✓. Willing to adhere to the SGLT2i + usual care regimen

Exclusion criteria

✕. Current use of SGLT2 inhibitor or use in the past 72 hours
✕. Pregnancy or lactation (a pregnancy test will be performed 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:

What they're measuring

Percentage of eligible versus consented patients

Timeframe: From study initiation to study close (about 2 years)

Percentage of enrolled patients with completed sample collections

Timeframe: From study initiation to study close (about 2 years)

Enrollment rate

Timeframe: From study initiation to study close (about 2 years)