Ventilator Lung Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 450 |
Est. completion date | October 9, 2030 |
Est. primary completion date | October 9, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
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. — View Citation
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. Erratum In: J Am Coll Cardiol. 2023 Apr 18;81(15):1551. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety parameters | Markers of volume depletion, hypotension and acute renal failure | 30 days | |
Primary | 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 | Components of the primary endpoint | Weaning failure, recurrent pulmonary edema, and cardiovascular/non-cardiovascular mortality. | 90 days | |
Secondary | Diuretic response | Any poor response to diuretics | after 15 and 30 days of treatment | |
Secondary | Change in NT-proBNP level | Difference between 30 days and baseline | over 30 days of treatment | |
Secondary | Occurrence of chronic dialysis or renal transplant or significant, sustained reduction of estimated glomerular filtration rate | Dialysis, renal transplant and eGFR | 90 days | |
Secondary | The therapeutic effect by different SGLT2i on components of the primary endpoint. | Empagliflozin vs Dapagliflozin | 90 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03909854 -
Pragmatic Investigation of Volume Targeted Ventilation-1
|
N/A | |
Completed |
NCT05690867 -
Pressure Controlled Ventilation Versus Volume Controlled Ventilation in Upper Abdominal Surgery
|
N/A | |
Enrolling by invitation |
NCT06151886 -
Life-dependent Home Mechanical Ventilation
|
||
Not yet recruiting |
NCT04229810 -
Individualized Perioperative Open Lung Ventilatory Approach in Emergency Abdominal Laparotomy. A Prospective Multicenter Randomized Controlled Trial.
|
N/A | |
Recruiting |
NCT06051188 -
FCV vs PCV in Moderate to Severe ARDS
|
N/A | |
Completed |
NCT04497090 -
Adaptive Non-invasive Ventilation to Abolish Tidal Flow Limitation
|
N/A | |
Completed |
NCT04581642 -
Nociception-Level (NOL) for the Assessment of Pain in Patient Unable to Self-Report
|
||
Recruiting |
NCT05134467 -
Assessment of Process and Outcome of Protocol-based Weaning From Mechanical Ventilation in the Medical Patients
|
||
Recruiting |
NCT05812365 -
Best End-Expiratory and Driving-pressure for Individualized Flow Controlled Ventilation in Patients With COPD
|
||
Recruiting |
NCT04376307 -
Minimal Flow Application in One Lung Ventilation
|
N/A | |
Recruiting |
NCT06178510 -
I-ASV in Cardiac Surgery
|
N/A | |
Recruiting |
NCT04484727 -
"Lung Barometric Measurements in Normal And in Respiratory Distressed Lungs"
|
||
Completed |
NCT03411239 -
Airway Pressure Changes Using Esophageal Balloon Catheter (OBC) in Laparoscopic Surgery
|
N/A | |
Recruiting |
NCT05116839 -
Pressure Support Ventilation Versus Continuous Positive Air Way Pressure (CPAP) Using I Gelin Adult Patients,
|
N/A | |
Recruiting |
NCT03420417 -
Respiratory Mechanics in Intensive Care Patients
|
N/A | |
Completed |
NCT04258202 -
Ventilator-driven Alveolar Recruitment Maneuver
|
N/A | |
Recruiting |
NCT04307459 -
Acute Respiratory Failure and COVID-19 in Real Life
|
||
Not yet recruiting |
NCT05726578 -
Integrated Echocardiography and Chest Ultrasound Assessment of Lung Recruitment in Preterm Infants
|
N/A | |
Completed |
NCT03558620 -
Effect of an Endoscopic Bite Block on Mask Ventilation
|
N/A | |
Completed |
NCT03226925 -
Mechanically-assisted Ventilation in the Treatment of Moving Tumours With Photon and Proton Therapies
|
N/A |