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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• 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 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:

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

Locations
Other Locations
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Chih Fan Yeh
nicholas.yeh@gmail.com
0972652306
Time Frame
Start Date: 2022-10-10
Estimated Completion Date: 2030-10-09
Participants
Target number of participants: 450
Treatments
No_intervention: acute decompensated HF Patients
acute decompensated HF Patients 2:1,have 50 Patients control and 100 Patients randomly assigned empagliflozin or dapagliflozin
Experimental: empagliflozin 10mg
acute decompensated HF Patients 2:1,have 50 Patients control and 100 Patients randomly assigned empagliflozin or dapagliflozin ,3 days before ventilator weaning in a ratio of 1:1.empagliflozin 10 mg once daily
Experimental: dapagliflozin 10mg
acute decompensated HF Patients 2:1,have 50 Patients control and 100 Patients randomly assigned empagliflozin or dapagliflozin ,3 days before ventilator weaning in a ratio of 2:1. dapagliflozin 10 mg once daily
Related Therapeutic Areas
Sponsors
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov

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