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

NCT06111768 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2000036118000
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiorenal Syndrome

Outcome Measures

Primary Outcomes (3)

• 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.

  From study initiation to study close (about 2 years)

• 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.

  From study initiation to study close (about 2 years)

• Enrollment rate

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

  From study initiation to study close (about 2 years)

Secondary Outcomes (12)

• Slope of creatinine

  5 days following randomization

• Slope of cystatin-C

  5 days following randomization

• Slope of NT-proBNP

  5 days following randomization

• Slope of kidney tubular injury and repair biomarkers

  5 days following randomization

• Slope of urine volume

  72 hours from randomization

Study Arms (2)

SGLT2i administration

EXPERIMENTAL

A 10 mg oral dose of dapagliflozin will be administered daily for three days.

Drug: Dapagliflozin

Usual Care

NO INTERVENTION

Subjects continue with usual care.

Interventions

Dapagliflozin DRUG

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

SGLT2i administration

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Yale University: lead
• American Heart Association: collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Cardio-Renal Syndrome

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Abinet Aklilu

  Yale University

  PRINCIPAL INVESTIGATOR

• Perry Wilson

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 1, 2023
• Study Start: May 30, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon publication; indefinitely.

Locations

US (1)