SGLT2 Inhibitors in Patients With ADHF During Ventilator Weaning

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Nov 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called SGLT2 inhibitors in patients who have acute heart failure and are in the process of being taken off ventilators. The goal is to see if these medications can help prevent heart and lung issues during this critical time. The trial is open to adults aged 20 and older who are currently hospitalized with heart failure, specifically those with a weakened heart (often measured by a test called LVEF) and certain other health criteria.

To participate, patients need to be stable enough, meaning their blood pressure is at a safe level, and they haven’t had recent increases in certain treatments. They also need to have specific heart-related blood test results. Participants will receive either the SGLT2 inhibitor or a placebo (a non-active treatment) to see how well the medication works. It’s important for potential participants and their families to know that this study is focused on improving care for patients with serious heart conditions, and the results may help shape future treatments.

Gender

ALL

Eligibility criteria

• 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