AzTrials
AzTrials

Cardiorenal SyndromePhase 2SGLT2i in CRSNCT06111768

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

A Phase 2 study testing Dapagliflozin in people with Cardiorenal Syndrome, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Cardiorenal Syndrome
What is being tested?
Dapagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
30 May 2024to 25 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

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
  • No healthy volunteers
  • 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
  • NT-proBNP > 300 pg/mL
  • Ability to take an oral medication
  • Willing to adhere to the SGLT2i + usual care regimen

Who cannot join

  • 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:
  • Documented history of ileal conduit (neobladder)
Show all 17Show fewer
  • 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 past 6 months or 3 x in the past 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

1 site in 1 country.

United States1 site

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520

Other trials in United States

About this study

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.

Read the detailed description

Acute heart failure is associated with a significant risk of acute kidney injury which is present in up to a third of patients at the time of hospitalization. As adequate kidney function is necessary for self-decongestion, kidney injury makes the treatment of acute heart failure particularly challenging. SGLT2i are drugs consistently shown to reduce hospitalizations in heart failure as well as progression of kidney disease but are frequently discontinued during acute kidney injury. Although they have been included in the armamentarium of heart failure care as guideline directed medical therapy, a concern about the efficacy and safety in patients with kidney dysfunction remains a limitation to their widespread uptake particularly during heart failure exacerbation.

This study aims to enroll adults hospitalized with acute congestive cardiorenal syndrome and develop acute kidney injury in a randomized clinical trial of SGLT2i versus usual care to compare markers of decongestion and biomarkers of kidney injury and health to inform a larger randomized clinical trial. The overall aim is to assess if SGLT2i improve diuretic efficiency in patients with heart failure associated kidney injury. The long-term goal of this study is to promote increased use of SGLT2i by demonstrating their safety and possible benefit in patients who develop heart failure associated kidney injury to avoid interruptions in this setting.

The primary objective of this is study is to test the feasibility and acceptability of randomizing adults hospitalized with acute heart failure complicated by acute kidney injury to SGLT2i or usual care.

The secondary objectives of this study are:

  1. To compare changes in biomarkers of kidney injury, repair and tubular function in order to test whether the SGLT2 inhibitor (dapagliflozin) improves response to standard treatment
  2. To compare markers of decongestion (weight, urine volume, symptom score, diuretic de-escalation) to test whether the addition of SGLT2i to standard of care improves heart failure symptoms faster.
  3. To compare possible adverse events such as: sodium or potassium derangements, metabolic acidosis, urinary tract infections (UTI) or genital mycotic infections in those exposed to the SGLT2i dapagliflozin vs usual care.
  4. To compare hospital length of stay, mortality, progression to a higher stage of AKI, and persistent AKI at discharge
Being tested
Dapagliflozin
Medical subject headings
Cardio-Renal Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DapagliflozinDrug

    Receipt of 10mg oral dose of dapagliflozin once daily for three days

Study groups in NCT06111768
Study groupRoleWhat they receive
SGLT2i administrationExperimentalA 10 mg oral dose of dapagliflozin will be administered daily for three days.
Receives: Drug: Dapagliflozin
Usual CareNo interventionSubjects continue with usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of eligible versus consented patients

    Number of patients deemed eligible after assessment of inclusion and exclusion criteria and number of patients who consent, which serves as a measure of feasibility of enrolling patients with acute cardiorenal syndrome in a randomized clinical trial of SGLT2i.

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

  2. Percentage of enrolled patients with completed sample collections

    Percentage of enrolled patients who have provided at least two days of urine samples and percentage of enrolled patients who have provided at least two days of blood samples, which serves as a measure of feasibility of enrolling and retaining patients with acute cardiorenal syndrome in a randomized clinical trial of SGLT2i.

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

  3. Enrollment rate

    Total enrollment into the study over study duration, to serve as a measure of feasibility.

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

Secondary outcomes (12)

  1. Slope of creatinine

    Comparison between study arms of the slope of the serum biomarker creatinine over five days, as a measure of kidney function

    Measured: 5 days following randomization

  2. Slope of cystatin-C

    Comparison between study arms of the slope of the serum biomarker cystatin-C over five days, as a measure of kidney function

    Measured: 5 days following randomization

  3. Slope of NT-proBNP

    Comparison between study arms of the slope of the serum biomarker NT-proBNP over five days, as a measure of decongestion.

    Measured: 5 days following randomization

  4. Slope of kidney tubular injury and repair biomarkers

    Comparison between study arms of the slopes of the following urinary biomarkers of renal tubular kidney injury, inflammation and repair over five days: molecule-1 (KIM-1), neutrophil gelatinase-associated lipocalin (NGAL), interleukin-18 (IL-18), monocyte chemoattractant protein-1 (MCP-1), uromodulin (UMOD), chitinase-3-like protein (YKL-40).

    Measured: 5 days following randomization

  5. Slope of urine volume

    Comparison between study arms of 24 hour urine volume collection as a measure of decongestion

    Measured: 72 hours from randomization

  6. Weight

    Weight of subjects at 72 hours post-randomization as a measure of decongestion.

    Measured: 72 hours from randomization

  7. Breathlessness score

    Based on the 3 item symptom scale questionnaire given to subjects. Breathlessness scores range from 1-5, with higher scores indicating higher breathlessness. This score serves as a measure of decongestion.

    Measured: 72 hours from randomization

  8. Loop diuretic dose de-escalation

    Time from randomization to de-escalation of loop diuretic, serving as a measure of decongestion.

    Measured: From randomization up to 72 hours from randomization

  9. Mortality

    Time to in-hospital death

    Measured: Assessed from randomization to time of death up to 14 days post-randomization or discharge

  10. Dialysis

    Time to in-hospital dialysis

    Measured: Assessed from point of randomization to the date of first documented dialysis order during index hospitalization, up to 14 days post-randomization or discharge

  11. Rate of rehospitalization with heart failure

    Number of patients rehospitalized for heat failure after index hospitalization, wtihin 90 days of discharge

    Measured: 90 days post-index discharge

  12. Time-to-prescription of an SGLT2i

    Time to prescription of any SGLT2 by patient's primary provider, up to 90 days post-randomization

    Measured: 90 days post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2023
  2. Study start30 May 2024
  3. Primary completion25 Sep 2025
  4. Study completion25 Dec 2025

Resources

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
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06111768
Sponsor's protocol ID
2000036118
Other IDs
000
Acronym
SGLT2i in CRS
Status last verified
Aug 2026
First submitted
23 Oct 2023
Last updated
13 Aug 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dapagliflozin in people with Cardiorenal Syndrome, run by Yale University at 1 site 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 17 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: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of eligible versus consented patients (time frame: From study initiation to study close (about 2 years)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06111768.

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 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in