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NCT06142474RecruitingPhase 3

SGLT2 Inhibitors in Patients With ADHF 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.

Source: ClinicalTrials.gov · Last updated 21 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
450 (estimated)
First submitted
16 Nov 2023
Start date
10 Oct 2022
Primary completion date
9 Oct 2030
Lead sponsor
National Taiwan University Hospital
NCT number
NCT06142474

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 450
  • From 10 Oct 2022 to the primary completion date, 9 Oct 2030
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Hospitalization for HF (HHF) triggered by acute myocardial infarction (AMI) or pulmonary embolism
  • Type 1 diabetes mellitus
  • Uncontrolled urinary tract infection

Lab values

  • Estimated glomerular filtration rate (eGFR) of less than 30 ml per minute per 1.73 m2 of body-surface area
  • Poorly controlled type 2 diabetes mellitus (a glycated hemoglobin level above 10.5%)

Other

  • Decision to withdraw life support
  • Cardiogenic shock

Who the study is looking for

  • 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:
    • 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:
    • 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 \[SpO2 \> 90% or PaO2/FiO2 ≥ 150 mmHg with a fraction of inspired oxygen (FiO2) ≤ 40% and a positive end-expiratory pressure (PEEP) ≤ 8 cmH2O\].

Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
National Taiwan University Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.