SGLT2 Inhibitors in Patients With ADHF During Ventilator Weaning

Recruiting now · Phase 3

Conditions studied: Heart Failure Acute, Ventilator Lung

In brief

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.

Key facts

Study ID

NCT06142474

Run by

National Taiwan University Hospital

People needed

450

Starts

2022-10-10

Expected to finish

2030-10-09

Last updated by the study team

2023-11-21

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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].

You may not qualify if…

• 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

Where it is running

• National Taiwan University Hospital — Taipei, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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