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SGLT2 Inhibitors in Patients With ADHF During Ventilator Weaning

ConditionsHeart Failure AcuteVentilator Lung
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Taiwan University Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged ≥20 years

Currently hospitalized for the primary diagnosis of acute HF (de novo or decompensated chronic HF) in HFrEF patients (LVEF≤40%)

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].

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • SGLT2 inhibitor

    Drug

    Patients with acute decompensated HF will be open-label randomly assigned to be treated with or without SGLT2 inhibitors (either empagliflozin 10 mg once daily or dapagliflozin 10 mg once daily) 3 days before ventilator weaning in a ratio of 2:1. If the patients are allocated to SGLT2i treatment group, they will be further randomized equally to either empagliflozin- or dapagliflozin-treated group

Treatment groups

450 Participants
are divided into 3 treatment groups
Group A: acute decompensated HF PatientsNo intervention 0 interventions
Group B: empagliflozin 10mgExperimental treatment 1 intervention
Group C: dapagliflozin 10mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Composite of weaning failure, recurrent pulmonary edema, and cardiovascular/non-cardiovascular mortality.

Weaning failure is defined that patient is reintubated within 7 days following extubation, irrespective of the use of noninvasive ventilation

Time frame
90 days

Secondary outcomes

1

Components of the primary endpoint

Weaning failure, recurrent pulmonary edema, and cardiovascular/non-cardiovascular mortality.

Time frame
90 days
2

Diuretic response

Any poor response to diuretics

Time frame
after 15 and 30 days of treatment
3

Change in NT-proBNP level

Difference between 30 days and baseline

Time frame
over 30 days of treatment
4

Occurrence of chronic dialysis or renal transplant or significant, sustained reduction of estimated glomerular filtration rate

Dialysis, renal transplant and eGFR

Time frame
90 days

Other outcomes

1

Safety parameters

Markers of volume depletion, hypotension and acute renal failure

Time frame
30 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Hospital

Lead sponsor

Source ClinicalTrials.gov
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