NCT06142474

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P50-P75 for phase_3

Timeline
53mo left

Started Oct 2022

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Oct 2022Oct 2030

Study Start

First participant enrolled

October 10, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2030

Last Updated

November 21, 2023

Status Verified

October 1, 2023

Enrollment Period

8 years

First QC Date

November 16, 2023

Last Update Submit

November 16, 2023

Conditions

Heart Failure AcuteVentilator Lung

Keywords

Heart Failure AcuteVentilator

Outcome Measures

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

    90 days

Secondary Outcomes (5)

  • Components of the primary endpoint

    90 days

  • Diuretic response

    after 15 and 30 days of treatment

  • Change in NT-proBNP level

    over 30 days of treatment

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

    90 days

  • The therapeutic effect by different SGLT2i on components of the primary endpoint.

    90 days

Other Outcomes (1)

  • Safety parameters

    30 days

Study Arms (3)

acute decompensated HF Patients

NO INTERVENTION

acute decompensated HF Patients 2：1，have 50 Patients control and 100 Patients randomly assigned empagliflozin or dapagliflozin

empagliflozin 10mg

EXPERIMENTAL

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

dapagliflozin 10mg

EXPERIMENTAL

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

Interventions

SGLT2 inhibitorDRUG

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

Also known as: Empagliflozin and dapagliflozin
dapagliflozin 10mgempagliflozin 10mg

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

You may not qualify 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
  • Type 1 diabetes mellitus
  • Poorly controlled type 2 diabetes mellitus (a glycated hemoglobin level above 10.5%)
  • Uncontrolled urinary tract infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (5)

  • McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.

    PMID: 31535829BACKGROUND

  • Anker SD, Butler J, Filippatos G, Ferreira JP, Bocchi E, Bohm M, Brunner-La Rocca HP, Choi DJ, Chopra V, Chuquiure-Valenzuela E, Giannetti N, Gomez-Mesa JE, Janssens S, Januzzi JL, Gonzalez-Juanatey JR, Merkely B, Nicholls SJ, Perrone SV, Pina IL, Ponikowski P, Senni M, Sim D, Spinar J, Squire I, Taddei S, Tsutsui H, Verma S, Vinereanu D, Zhang J, Carson P, Lam CSP, Marx N, Zeller C, Sattar N, Jamal W, Schnaidt S, Schnee JM, Brueckmann M, Pocock SJ, Zannad F, Packer M; EMPEROR-Preserved Trial Investigators. Empagliflozin in Heart Failure with a Preserved Ejection Fraction. N Engl J Med. 2021 Oct 14;385(16):1451-1461. doi: 10.1056/NEJMoa2107038. Epub 2021 Aug 27.

    PMID: 34449189BACKGROUND

  • Spertus JA, Birmingham MC, Nassif M, Damaraju CV, Abbate A, Butler J, Lanfear DE, Lingvay I, Kosiborod MN, Januzzi JL. The SGLT2 inhibitor canagliflozin in heart failure: the CHIEF-HF remote, patient-centered randomized trial. Nat Med. 2022 Apr;28(4):809-813. doi: 10.1038/s41591-022-01703-8. Epub 2022 Feb 28.

    PMID: 35228753BACKGROUND

  • Solomon SD, McMurray JJV, Claggett B, de Boer RA, DeMets D, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Desai AS, Jhund PS, Belohlavek J, Chiang CE, Borleffs CJW, Comin-Colet J, Dobreanu D, Drozdz J, Fang JC, Alcocer-Gamba MA, Al Habeeb W, Han Y, Cabrera Honorio JW, Janssens SP, Katova T, Kitakaze M, Merkely B, O'Meara E, Saraiva JFK, Tereshchenko SN, Thierer J, Vaduganathan M, Vardeny O, Verma S, Pham VN, Wilderang U, Zaozerska N, Bachus E, Lindholm D, Petersson M, Langkilde AM; DELIVER Trial Committees and Investigators. Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. 2022 Sep 22;387(12):1089-1098. doi: 10.1056/NEJMoa2206286. Epub 2022 Aug 27.

    PMID: 36027570BACKGROUND

  • Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 May 3;79(17):e263-e421. doi: 10.1016/j.jacc.2021.12.012. Epub 2022 Apr 1.

    PMID: 35379503BACKGROUND

MeSH Terms

Interventions

Sodium-Glucose Transporter 2 Inhibitorsempagliflozindapagliflozin

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of Drugs

Central Study Contacts

Chih Fan Yeh

CONTACT

0972652306nicholas.yeh@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chih Fan Yeh, MD, PhD

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 21, 2023

Study Start

October 10, 2022

Primary Completion (Estimated)

October 9, 2030

Study Completion (Estimated)

October 9, 2030

Last Updated

November 21, 2023

Record last verified: 2023-10

Locations

TW(1)