Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-30 @ 2:53 AM
Study NCT ID:
NCT06111768
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2023-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sodium-Glucose Cotransporter-2 Inhibitor for Acute Cardiorenal Syndrome: A Feasibility Study
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Sodium-Glucose Cotransporter-2 Inhibitor for Acute Cardiorenal Syndrome: A Feasibility Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SGLT2i in CRS
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.
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 000 | OTHER | CTGTY | View |