SGLT2 Inhibitors in Patients With ADHF During Ventilator Weaning
The Potential Beneficial Effects of SGLT2 Inhibitors in Patients With Acute Decompensated Heart Failure During Ventilator Weaning: a Prospective Multicenter Cohort Study.
National Taiwan University Hospital
450 participants
Oct 10, 2022
INTERVENTIONAL
Conditions
Summary
This study will explore the potential benefits of sodium-glucose cotransporter 2 (SGLT2) inhibitors in preventing cardiac ischemia and cardiopulmonary edema in patients with acute decompensated heart failure during weaning from ventilators.
Eligibility
Inclusion Criteria7
- Patients aged ≥20 years
- Currently hospitalized for the primary diagnosis of acute HF (de novo or decompensated chronic HF) in HFrEF patients (LVEF≤40%)
- Meet the stabilization criteria:
- A. Systolic BP ≥100mm Hg and no symptoms of hypotension in the preceding 6 hours B. No increase in i.v. diuretic dose for 6 hours prior to randomization C. No i.v. vasodilators including nitrates within the last 6 hours prior to randomization D. No i.v. inotropic drugs for 24 hours prior to randomization
- Elevated N-terminal proB-type natriuretic peptide (NT-proBNP) or BNP:
- A. Without atrial fibrillation (AF): NT-proBNP ≥1600 pg/mL or BNP ≥400 pg/mL B. With AF: NT-proBNP ≥2400 pg/mL or BNP ≥600 pg/mL
- Patients were intubated for at least 24 hour with ventilator settings allowing to initiate the weaning process \[SpO2 \> 90% or PaO2/FiO2 ≥ 150 mmHg with a fraction of inspired oxygen (FiO2) ≤ 40% and a positive end-expiratory pressure (PEEP) ≤ 8 cmH2O\].
Exclusion Criteria9
- Decision to withdraw life support
- Cardiogenic shock
- Hospitalization for HF (HHF) triggered by acute myocardial infarction (AMI) or pulmonary embolism
- Planned or previous (within 30 days) cardiovascular revascularization or major cardiac surgery/intervention/device implantation
- Prior acute coronary syndrome, AMI, stroke or transient ischemic accident within 90 days
- Estimated glomerular filtration rate (eGFR) of less than 30 ml per minute per 1.73 m2 of body-surface area
- Type 1 diabetes mellitus
- Poorly controlled type 2 diabetes mellitus (a glycated hemoglobin level above 10.5%)
- Uncontrolled urinary tract infection
Interventions
Patients with acute decompensated HF will be open-label randomly assigned to be treated with or without SGLT2 inhibitors (either empagliflozin 10 mg once daily or dapagliflozin 10 mg once daily) 3 days before ventilator weaning in a ratio of 2:1. If the patients are allocated to SGLT2i treatment group, they will be further randomized equally to either empagliflozin- or dapagliflozin-treated group
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06142474