SGLT2 Inhibitors in Patients With ADHF During Ventilator Weaning

November 16, 2023 updated by: National Taiwan University Clinical Trial Center, National Taiwan University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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. A series of examination will be performed to detect weaning-induced cardiac ischemia and weaning-induced cardiopulmonary edema, including electrocardiography, chest X-ray, echocardiography, and biomarkers.

Echocardiography Transthoracic echocardiography (TTE) will be performed by a trained operator at several time points: (1) before SBT and SGLT2i initiation; (2) during SBT trial just after initiating SGLT2 inhibitor; (3) during SBT trial 3 days after initiation of SGLT2 inhibitor; (4) within 24 hrs after extubation; (5) 7-10 days after extubation; (6) 90±7 days after extubation.

Biomarkers NT-proBNP, plasma protein, high-sensitive cardiac troponin T, and hemoglobin level will be checked at several time points: (1) before spontaneous breathing trial (SBT), (2) during SBT trial (at least 10 mins after the initiation of SBT) just after initiating SGLT2 inhibitor; (3) during SBT (at least 10 mins after the initiation of SBT) trial 3 days after SGLT2 inhibitor; (4) within 24 hrs after extubation; (5) 7~10 days after extubation; (5) 90±7 days after extubation. We will also check arterial blood gas analyses at the end of SBT trial just after initiating SGLT2 inhibitor and 3 days after SGLT2 inhibitor.

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: SGLT2 inhibitor
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
Other Names:
  • Empagliflozin and dapagliflozin
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
Drug: SGLT2 inhibitor
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
Other Names:
  • Empagliflozin and dapagliflozin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of weaning failure, recurrent pulmonary edema, and cardiovascular/non-cardiovascular mortality.
Time Frame: 90 days
Weaning failure is defined that patient is reintubated within 7 days following extubation, irrespective of the use of noninvasive ventilation
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Components of the primary endpoint
Time Frame: 90 days
Weaning failure, recurrent pulmonary edema, and cardiovascular/non-cardiovascular mortality.
90 days
Diuretic response
Time Frame: after 15 and 30 days of treatment
Any poor response to diuretics
after 15 and 30 days of treatment
Change in NT-proBNP level
Time Frame: over 30 days of treatment
Difference between 30 days and baseline
over 30 days of treatment
Occurrence of chronic dialysis or renal transplant or significant, sustained reduction of estimated glomerular filtration rate
Time Frame: 90 days
Dialysis, renal transplant and eGFR
90 days
The therapeutic effect by different SGLT2i on components of the primary endpoint.
Time Frame: 90 days
Empagliflozin vs Dapagliflozin
90 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety parameters
Time Frame: 30 days
Markers of volume depletion, hypotension and acute renal failure
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2022

Primary Completion (Estimated)

October 9, 2030

Study Completion (Estimated)

October 9, 2030

Study Registration Dates

First Submitted

November 16, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Actual)

November 21, 2023

Study Record Updates

Last Update Posted (Actual)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202209061MINA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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