Heart FailurePhase 2NCT07273838
Sodium-Glucose Cotransporter-2 Inhibitor for Patients With Acute Cardiorenal Syndrome
A Phase 2 study testing Dapagliflozin 10mg Tab in people with Heart Failure and Acute Kidney Injury, run by Yale University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Acute Kidney Injury
- What is being tested?
- Dapagliflozin 10mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Mar 2026to 31 Oct 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 18Show fewer
- 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 3 x in the preceding 12 months
- End-stage kidney disease with dialysis requirement
- 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
- Severe acute kidney injury with indications for dialysis
- Current dialysis receipt for acute kidney injury
- Comfort measures only
- Solid organ transplant on immunosuppression
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Francis Wilson contact
United States2 sites, 2 recruiting
- Recruiting
Yale New Haven Hospital-St. Raphael Campus
New Haven, Connecticut, 06510
Abinet Aklilu, MD
- Recruiting
Yale New Haven Hospital
New Haven, Connecticut, 06510
Abinet Aklilu, MD
About this study
Official title: Sodium-Glucose Cotransporter-2 Inhibitor for Amelioration of Acute Cardiorenal Syndrome: A Randomized Controlled 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.
Read the detailed description
Individuals with heart failure are prone to acute kidney injury (AKI) as well as fluctuations in creatinine that meet AKI criteria. AKI diagnosis often complicates heart failure management and leads to interruptions of medications with long term benefit. AKI is also associated with long-term complications such as chronic kidney function and cardiovascular mortality. There is no efficient universal treatment for this type of AKI. In acute heart failure (AHF), although loop diuretics are the mainstay of treatment, diuretic resistance complicates the management. A drug that improves diuretic efficiency may lead to faster decongestion and improvement in kidney function.
Sodium-glucose co-transporter-2 inhibitors (SGLT2i) are drugs consistently shown to reduce hospitalizations in heart failure as well as progression of chronic kidney disease. They have also shown to promote kidney tubular health in pre-clinical models of kidney injury. They have been included in the armamentarium of heart failure care as goal directed medical therapy (GDMT) but concerns of efficacy and safety in patients with kidney dysfunction continue to limit their uptake and maintenance.
This study aims to promote increased use of SGLT2 inhibitors by demonstrating their safety and possible benefit in patients who develop kidney injury in the setting of heart failure to avoid interruptions in GDMT use.
To this end, 130 hospitalized adults with acute cardiorenal syndrome will be enrolled into a randomized controlled trial. Subjects will be randomized to receive either dapagliflozin or placebo for 14 days or until discharge (whichever comes first). Blood and urine samples will be collected for biomarker analysis, symptom and adverse event surveys will be administered, and various clinical parameters will be recorded on up to 6 study visits during hospitalization.
The primary outcome is a composite of short- and intermediate-term cardiorenal outcomes including: heart failure specific outcomes (objective measures of decongestion (i.e., effective diuresis), and a patient-reported outcome incorporating two dimensions of health state and a visual analogue scale (VAS)), kidney-specific outcomes (dialysis receipt, AKI progression to a higher stage, and change in serum creatinine), length of stay, and mortality. Secondary outcomes include trends in biomarkers of kidney injury, inflammation, oxidative stress, and repair, as well as individual components of the primary outcome as well as re-hospitalization rates.
- Conditions
- Heart Failure, Acute Kidney Injury
- Being tested
- Dapagliflozin 10mg Tab, Placebo
- Keywords
- Acute cardiorenal syndrome
- Medical subject headings
- Heart Failure, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mg TabDrug
Administration of 10mg oral dapagliflozin once daily for 14 days (or until discharge).
PlaceboDrug
Administration of placebo comparator once daily for 14 days (or until discharge).
| Study group | Role | What they receive |
|---|---|---|
| SGLT2i | Experimental | 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. Receives: Drug: Dapagliflozin 10mg Tab |
| Placebo | Placebo comparator | Subjects receive once daily administration of a placebo comparator for 14 days (or until discharge). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardio-renal clinical improvement calculated as a Win Ratio
This outcome is assessed using a win ratio (total wins in the intervention group divided by total wins in the control group). Pairwise comparisons of predetermined components are made between each participant in the intervention and control group hierarchically in order of clinical importance, with a "win" assigned to the participant with the more favorable result at the first level of difference. The win ratio is the number of "winning" pairs for the treatment group divided by the number of "losing" pairs, with a win ratio greater than 1 indicating a benefit for the treatment.
Measured: Calculated at 30 days post-randomization
Secondary outcomes (30)
Change in slope of serum creatinine over 14 days from enrollment
Measure of kidney function; assessed as a change in blood concentration.
Measured: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of serum cystatin-C over 14 days from enrollment
Measure of kidney function; assessed as a change in blood concentration.
Measured: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of serum serum NT-proBNP over 14 days from enrollment
Measure of kidney function; assessed as a change in blood concentration.
Measured: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of blood kidney injury molecule-1 (KIM-1) over 14 days from enrollment
Biomarker of renal tubular injury; assessed as a change in blood concentration.
Measured: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of urine kidney injury molecule-1 (KIM-1) over 14 days from enrollment
Biomarker of renal tubular injury; assessed as a change in urine concentration.
Measured: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of blood neutrophil gelatinase-associated lipocalin (NGAL) over 14 days from enrollment
Biomarker of renal tubular injury; assessed as a change in blood concentration.
Measured: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of urine neutrophil gelatinase-associated lipocalin (NGAL) over 14 days from enrollment
Biomarker of renal tubular injury; assessed as a change in urine concentration.
Measured: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of blood interleukin-6 (IL-6) over 14 days from enrollment
Biomarker of inflammation; assessed as a change in blood concentration.
Measured: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of urine interleukin-6 (IL-6) over 14 days from enrollment
Biomarker of inflammation; assessed as a change in urine concentration.
Measured: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of blood interluekin-18 (IL-18) over 14 days from enrollment
Biomarker of inflammation; assessed as a change in blood concentration.
Measured: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of urine interluekin-18 (IL-18) over 14 days from enrollment
Biomarker of inflammation; assessed as a change inurine concentration.
Measured: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of blood MPO over 14 days from enrollment
Biomarker of oxidative stress; assessed as a change in blood concentration.
Measured: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of urine MPO over 14 days from enrollment
Biomarker of oxidative stress; assessed as a change in urine concentration.
Measured: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of blood uromodulin (UMOD) over 14 days from enrollment
Biomarker of repair; assessed as a change in blood concentration.
Measured: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of urine uromodulin (UMOD) over 14 days from enrollment
Biomarker of repair; assessed as a change in urine concentration.
Measured: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of blood chitinase-3-like protein 1 (YKL-40) over 14 days from enrollment
Biomarker of repair. Assessed as a change in blood concentration.
Measured: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of urine chitinase-3-like protein 1 (YKL-40) over 14 days from enrollment
Biomarker of repair. Assessed as a change in urine concentration.
Measured: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of urine volume over 5 days from enrollment
Measure of decongestion; measured daily (i.e. every 24 hours) according to floor protocol.
Measured: Measured at the time of enrollment (day 0) and on days 1-4 post-enrollment
Change in slope of weight over 14 days from enrollment
Measure of decongestion; assessed upon physical exam.
Measured: Measured at the time of enrollment (day 0) and on days 1-4 and 14 post-enrollment
Change in slope of breathlessness score over 14 days from enrollment
Measure of decongestion using a survey, scored on a Likert scale from 1-5 (5 indicates more severe breathlessness).
Measured: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 post-enrollment
Change in slope of edema grade over 14 days from enrollment
Measure of decongestion; a score from 0 to 4+ is given on physical examination, with a higher score indicating higher edema.
Measured: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 post-enrollment
Change in slope of patient-reported edema over 14 days from enrollment
Measure of decongestion using a survey, scored on a Likert scale from 1-5 (5 indicates more severe edema).
Measured: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 post-enrollment
Change in slope of patient-reported VAS dyspnea score over 14 days from enrollment
A patient reported outcome measured on a visual analog scale of 1-100mm, with 100 indicating worse breathlessness.
Measured: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 post-enrollment
Cumulative Lasix equivalent diuretic dose over 5 days
Measure of decongestion
Measured: Up to 5 days from enrollment
Proportion with kidney injury progression
Proportion with dialysis receipt or AKI progression to a higher stage up to 14 days from enrollment
Measured: Up to 14 days post-enrollment
Percent survival at 30 days post-enrollment
Percent of subject's surviving to 30 days post-enrollment
Measured: Up to 30 days post-enrollment
Percent of subjects re-hospitalized with heart failure and AKI at 30 days post-enrollment
Percent of rehospitalization up to 30 days post-enrollment
Measured: Up to 30 days post-enrollment
Proportion with prescription of SGLT2i
Proportion with prescription of SGLT2i by subject's own provider
Measured: Up to 30 days post-enrollment
Incidence of adverse events during exposure
Number of adverse events experienced by subjects, including sodium or potassium derangements, metabolic acidosis, urinary tract infections, fungal genitourinary infection, hypotension, allergic reactions, and hypoglycemia
Measured: Up to 14 days post-enrollment or until hospital discharge
Change in heart failure symptoms (mobility and self care)
Change in score using a full and modified version of the EQ-5D-5L-VAS. The full questionnaire contains 5 dimensions of state of health and the VAS (visual analog scale) addressing perceived overall health and will be conducted on day 0 and 14. The modified version contains two dimensions of health (self care and mobility) and the VAS scale, and will be conducted on days 1, 2, 3, and 4. The EQ-5D-5L dimensions are scored on a Likert Scale from 1-5, with 5 indicating worsening health. The VAS is scored on a scale of 1 to 100, with 100 indicating better perceived overall health.
Measured: Measured on Days 0, 1, 2, 3, 4, and 14 post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start5 Mar 2026
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abinet Aklilu, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273838
- Sponsor's protocol ID
- 2000038989
- Other IDs
- 1K23DK142042-01A1
- Status last verified
- Mar 2026
- First submitted
- 8 Aug 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data for the primary and secondary outcomes will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium-Glucose Cotransporter-2 Inhibitor for Amelioration of Acute Cardiorenal Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07273838
- Acronym / sponsor ID
- 2000038989
- Conditions
- Heart Failure, Acute Kidney Injury
- Keywords
- Acute cardiorenal syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Individuals with heart failure are prone to acute kidney injury (AKI) as well as fluctuations in creatinine that meet AKI criteria. AKI diagnosis often complicates heart failure management and leads to interruptions of medications with long term benefit. AKI is also associated with long-term complications such as chronic kidney function and cardiovascular mortality. There is no efficient universal treatment for this type of AKI. In acute heart failure (AHF), although loop diuretics are the mainstay of treatment, diuretic resistance complicates the management. A drug that improves diuretic efficiency may lead to faster decongestion and improvement in kidney function.
Sodium-glucose co-transporter-2 inhibitors (SGLT2i) are drugs consistently shown to reduce hospitalizations in heart failure as well as progression of chronic kidney disease. They have also shown to promote kidney tubular health in pre-clinical models of kidney injury. They have been included in the armamentarium of heart failure care as goal directed medical therapy (GDMT) but concerns of efficacy and safety in patients with kidney dysfunction continue to limit their uptake and maintenance.
This study aims to promote increased use of SGLT2 inhibitors by demonstrating their safety and possible benefit in patients who develop kidney injury in the setting of heart failure to avoid interruptions in GDMT use.
To this end, 130 hospitalized adults with acute cardiorenal syndrome will be enrolled into a randomized controlled trial. Subjects will be randomized to receive either dapagliflozin or placebo for 14 days or until discharge (whichever comes first). Blood and urine samples will be collected for biomarker analysis, symptom and adverse event surveys will be administered, and various clinical parameters will be recorded on up to 6 study visits during hospitalization.
The primary outcome is a composite of short- and intermediate-term cardiorenal outcomes including: heart failure specific outcomes (objective measures of decongestion (i.e., effective diuresis), and a patient-reported outcome incorporating two dimensions of health state and a visual analogue scale (VAS)), kidney-specific outcomes (dialysis receipt, AKI progression to a higher stage, and change in serum creatinine), length of stay, and mortality. Secondary outcomes include trends in biomarkers of kidney injury, inflammation, oxidative stress, and repair, as well as individual components of the primary outcome as well as re-hospitalization rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGLT2i | Experimental | Drug: Dapagliflozin 10mg TabSubjects 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 | Placebo comparator | Drug: PlaceboSubjects receive once daily administration of a placebo comparator for 14 days (or until discharge). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10mg TabAdministration of 10mg oral dapagliflozin once daily for 14 days (or until discharge). | Drug | SGLT2i |
| PlaceboAdministration of placebo comparator once daily for 14 days (or until discharge). | Drug | Placebo |
Primary outcome
Cardio-renal clinical improvement calculated as a Win Ratio
Time frame: Calculated at 30 days post-randomization
This outcome is assessed using a win ratio (total wins in the intervention group divided by total wins in the control group). Pairwise comparisons of predetermined components are made between each participant in the intervention and control group hierarchically in order of clinical importance, with a "win" assigned to the participant with the more favorable result at the first level of difference. The win ratio is the number of "winning" pairs for the treatment group divided by the number of "losing" pairs, with a win ratio greater than 1 indicating a benefit for the treatment.
30 secondary outcomes
Change in slope of serum creatinine over 14 days from enrollment
Time frame: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of serum cystatin-C over 14 days from enrollment
Time frame: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of serum serum NT-proBNP over 14 days from enrollment
Time frame: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of blood kidney injury molecule-1 (KIM-1) over 14 days from enrollment
Time frame: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of urine kidney injury molecule-1 (KIM-1) over 14 days from enrollment
Time frame: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of blood neutrophil gelatinase-associated lipocalin (NGAL) over 14 days from enrollment
Time frame: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of urine neutrophil gelatinase-associated lipocalin (NGAL) over 14 days from enrollment
Time frame: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of blood interleukin-6 (IL-6) over 14 days from enrollment
Time frame: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of urine interleukin-6 (IL-6) over 14 days from enrollment
Time frame: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of blood interluekin-18 (IL-18) over 14 days from enrollment
Time frame: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of urine interluekin-18 (IL-18) over 14 days from enrollment
Time frame: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of blood MPO over 14 days from enrollment
Time frame: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of urine MPO over 14 days from enrollment
Time frame: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of blood uromodulin (UMOD) over 14 days from enrollment
Time frame: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of urine uromodulin (UMOD) over 14 days from enrollment
Time frame: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of blood chitinase-3-like protein 1 (YKL-40) over 14 days from enrollment
Time frame: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of urine chitinase-3-like protein 1 (YKL-40) over 14 days from enrollment
Time frame: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 +/- 4 days
Change in slope of urine volume over 5 days from enrollment
Time frame: Measured at the time of enrollment (day 0) and on days 1-4 post-enrollment
Change in slope of weight over 14 days from enrollment
Time frame: Measured at the time of enrollment (day 0) and on days 1-4 and 14 post-enrollment
Change in slope of breathlessness score over 14 days from enrollment
Time frame: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 post-enrollment
Change in slope of edema grade over 14 days from enrollment
Time frame: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 post-enrollment
Change in slope of patient-reported edema over 14 days from enrollment
Time frame: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 post-enrollment
Change in slope of patient-reported VAS dyspnea score over 14 days from enrollment
Time frame: Measured at the time of enrollment (day 0) and on days 1-4, and day 14 post-enrollment
Cumulative Lasix equivalent diuretic dose over 5 days
Time frame: Up to 5 days from enrollment
Proportion with kidney injury progression
Time frame: Up to 14 days post-enrollment
Percent survival at 30 days post-enrollment
Time frame: Up to 30 days post-enrollment
Percent of subjects re-hospitalized with heart failure and AKI at 30 days post-enrollment
Time frame: Up to 30 days post-enrollment
Proportion with prescription of SGLT2i
Time frame: Up to 30 days post-enrollment
Incidence of adverse events during exposure
Time frame: Up to 14 days post-enrollment or until hospital discharge
Change in heart failure symptoms (mobility and self care)
Time frame: Measured on Days 0, 1, 2, 3, 4, and 14 post-enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified data for the primary and secondary outcomes will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francis Wilson contact
Abinet Aklilu, MD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapagliflozin 10mg Tab in people with Heart Failure and Acute Kidney Injury, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abinet Aklilu, MD (203-931-5064, abinet.aklilu@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardio-renal clinical improvement calculated as a Win Ratio (time frame: Calculated at 30 days post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.