Tests SGLT2 inhibitors in heart failure patients weaning from ventilators
Tests an SGLT2 inhibitor drug in adults with acute heart failure during ventilator weaning.
Plain-language title generated from the registry record
Registry title: SGLT2 Inhibitors in Patients With ADHF During Ventilator Weaning
Key facts
- Where
- Taipei, TaiwanSee the site
- Phase
- Phase 3
Where in Taiwan
- National Taiwan University HospitalTaipei, TaiwanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Taiwan University Hospital
- Trial code
- NCT06142474
- Record updated
- 21 November 2023
- Original description
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.Read full original descriptionShow less
The Potential Beneficial Effects of SGLT2 Inhibitors in Patients With Acute Decompensated Heart Failure During Ventilator Weaning: a Prospective Multicenter Cohort Study.
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.
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:; 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:; 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: 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; Hospitalization for HF (HHF) triggered by acute myocardial infarction (AMI) or pulmonary embolism; Type 1 diabetes mellitus; Uncontrolled urinary tract infection; Estimated glomerular filtration rate (eGFR) of less than 30 ml per minute per 1.73 m2 of body-surface area; Poorly controlled type 2 diabetes mellitus (a glycated hemoglobin level above 10.5%); Decision to withdraw life support; Cardiogenic shock.