Sodium-Glucose Cotransporter-2 Inhibitor for Patients With Acute Cardiorenal Syndrome (NCT07273838) | Clinical Trial Compass
RecruitingPhase 2
Sodium-Glucose Cotransporter-2 Inhibitor for Patients With Acute Cardiorenal Syndrome
United States130 participantsStarted 2026-03-05
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
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
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cardio-renal clinical improvement calculated as a Win Ratio
Timeframe: Calculated at 30 days post-randomization