The Potential Beneficial Effects of SGLT2 Inhibitors in Patients With Acute Decompensated Heart Failure During Ventilator Weaning: a Prospective Multicenter Cohort Study.

202209061MINA

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.

2022-10-10

2030-10-09

2030-10-09

Recruiting

Early phase I

450

Inclusion Criteria: 1. Patients aged ≥20 years 2. Currently hospitalized for the primary diagnosis of acute HF (de novo or decompensated chronic HF) in HFrEF patients (LVEF≤40%) 3. 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 4. 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 5. 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 Criteria: 1. Decision to withdraw life support 2. Cardiogenic shock 3. Hospitalization for HF (HHF) triggered by acute myocardial infarction (AMI) or pulmonary embolism 4. Planned or previous (within 30 days) cardiovascular revascularization or major cardiac surgery/intervention/device implantation 5. Prior acute coronary syndrome, AMI, stroke or transient ischemic accident within 90 days 6. Estimated glomerular filtration rate (eGFR) of less than 30 ml per minute per 1.73 m2 of body-surface area 7. Type 1 diabetes mellitus 8. Poorly controlled type 2 diabetes mellitus (a glycated hemoglobin level above 10.5%) 9. Uncontrolled urinary tract infection

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 450, 'type': 'ESTIMATED'}}

2023-11-21