Using SGLT2 inhibitors for heart failure patients during ventilator weaning

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• National Taiwan University Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Chih Fan Yeh
• Email: nicholas.yeh@gmail.com
• Phone: 0972652306

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.