Recruiting PHASE3 Heart Failure Acute

New treatment option for Heart Failure Acute

Official title SGLT2 Inhibitors in Patients With ADHF During Ventilator Weaning

ClinicalTrials.gov ID: NCT06142474

What this study is testing

What is SGLT2 inhibitor?

SGLT2 inhibitor is an investigational medicine, given as an once-daily, being studied as a potential treatment for heart failure acute.

Also referred to as Empagliflozin and dapagliflozin.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 3: a large, late-stage study
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 20 and older

You may be able to join 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...
  • 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...
  • Patients were intubated for at least 24 hour with ventilator settings allowing to initiate the weaning process [SpO2 \> 90% or PaO2/FiO2 ≥ 150 mmHg...

You likely can't join 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
See the full eligibility criteria
Who can join
  • 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...
  • 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...
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Taipei, Taiwan

Compensation & support

A stipend or compensation may be offered.

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.