ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-30

Study Completion:2026-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06111768

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged ≥ 18 and ≤ 85 years-old 4. Diagnosed with heart failure of either preserved or reduced left ventricular function 5. NT-proBNP \> 300 pg/mL 6. Ability to take an oral medication 7. Willing to adhere to the SGLT2i + usual care regimen	1. Current use of SGLT2 inhibitor or use in the past 72 hours 2. Pregnancy or lactation (a pregnancy test will be performed prior to enrollment in women of child-bearing age) 3. Known allergic reactions to components of an SGLT2 inhibitor 4. Treatment with another investigational drug for heart failure different from or in addition to usual care within the 72 hours preceding AKI 5. 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 * Comfort measures only * Solid organ transplant on immunosuppression

Inclusion Criteria

Exclusion Criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged ≥ 18 and ≤ 85 years-old
4. Diagnosed with heart failure of either preserved or reduced left ventricular function
5. NT-proBNP \> 300 pg/mL
6. Ability to take an oral medication
7. Willing to adhere to the SGLT2i + usual care regimen

1. Current use of SGLT2 inhibitor or use in the past 72 hours
2. Pregnancy or lactation (a pregnancy test will be performed prior to enrollment in women of child-bearing age)
3. Known allergic reactions to components of an SGLT2 inhibitor
4. Treatment with another investigational drug for heart failure different from or in addition to usual care within the 72 hours preceding AKI
5. 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
* Comfort measures only
* Solid organ transplant on immunosuppression

Contacts and Locations

Principal Investigator

Abinet Aklilu

PRINCIPAL_INVESTIGATOR

Yale University

Perry Wilson

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Yale New Haven Hospital

New Haven, Connecticut, 06520

United States

Collaborators and Investigators

Sponsor: Yale University

Abinet Aklilu, PRINCIPAL_INVESTIGATOR, Yale University
Perry Wilson, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-30

Study Completion Date2026-05

Study Record Updates

Study Start Date2024-05-30

Study Completion Date2026-05

Terms related to this study

Additional Relevant MeSH Terms

Cardiorenal Syndrome