Using SGLT2 inhibitors for heart failure patients during ventilator weaning

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

This study is testing if giving heart failure patients SGLT2 inhibitors while they are being taken off ventilators can help them recover better.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: National Taiwan University Hospital (other)
• Locations: 1 site (Taipei)
• Trial ID: NCT06142474 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of sodium-glucose cotransporter 2 (SGLT2) inhibitors on patients with acute decompensated heart failure who are being weaned off ventilators. Participants will be randomly assigned to receive either SGLT2 inhibitors or standard care three days prior to the weaning process. The study will monitor various parameters, including cardiac ischemia and cardiopulmonary edema, through electrocardiography, chest X-rays, echocardiography, and biomarker analysis at multiple time points. The goal is to determine if SGLT2 inhibitors can improve outcomes during this critical transition.

Who should consider this trial

Good fit: Ideal candidates are hospitalized adults aged 20 and older with acute heart failure and specific stabilization criteria.

Not a fit: Patients who are not intubated or do not meet the stabilization criteria for weaning may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce the risk of cardiac complications and improve recovery for patients with acute heart failure during ventilator weaning.

How similar studies have performed: While the use of SGLT2 inhibitors in heart failure is gaining attention, this specific application during ventilator weaning is relatively novel and has not been extensively tested.

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

Where this trial is running

Taipei

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

Study contacts

• Study coordinator: Chih Fan Yeh

Conditions: Heart Failure Acute, Ventilator Lung, Ventilator