Status:
RECRUITING
SGLT2 Inhibitors in Patients With ADHF During Ventilator Weaning
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Heart Failure Acute
Ventilator Lung
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
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 day...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 9 2030
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT06142474
Start Date
October 10 2022
End Date
October 9 2030
Last Update
November 21 2023
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100