Sodium-Glucose Cotransporter-2 Inhibitor for Amelioration of Acute Cardiorenal Syndrome: A Randomized Controlled Trial
Yale University
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. 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.
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 effi…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 Exclusion Criteria: * AKI can be primarily explained by another etiology * Current use of SGLT2 inhibitor or exposure in the past 72 hours * Pregnancy…
Interventions
- DrugDapagliflozin 10mg Tab
Administration of 10mg oral dapagliflozin once daily for 14 days (or until discharge).
- DrugPlacebo
Administration of placebo comparator once daily for 14 days (or until discharge).
Locations (2)
- Yale New Haven Hospital-St. Raphael CampusNew Haven, Connecticut
- Yale New Haven HospitalNew Haven, Connecticut