Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction.
John J V McMurray, Scott D Solomon, Silvio E Inzucchi...
https://pubmed.ncbi.nlm.nih.gov/31535829Actively Recruiting
Phase 3
Age: 20Years +
All Genders
ID06142474
The Potential Beneficial Effects of SGLT2 Inhibitors in Patients With Acute Decompensated Heart Failure During Ventilator Weaning: a Prospective Multicenter Cohort Study
Led by National Taiwan University Hospital · Updated on 2023-11-21
450
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the possible benefits of sodium-glucose cotransporter 2 (SGLT2) inhibitors in patients with acute decompensated heart failure (HF) who are being weaned off ventilators. The study aims to evaluate if these drugs can help prevent heart-related blood flow problems and lung fluid buildup during the ventilator weaning process. This is a phase 3, open-label, randomized trial sponsored by National Taiwan University Hospital. Patients hospitalized for acute HF will be randomly assigned in a 2:1 ratio to receive either SGLT2 inhibitors or no SGLT2 treatment. Those in the treatment group will be further randomly assigned to take either empagliflozin 10 mg once daily or dapagliflozin 10 mg once daily, starting three days before ventilator weaning. Several tests, including electrocardiograms, chest X-rays, echocardiograms, and blood biomarker measurements, will be performed to monitor heart and lung status at multiple time points before, during, and after the weaning process. Participants will undergo transthoracic echocardiography and blood tests for markers like NT-proBNP and cardiac troponin T at scheduled intervals: before starting treatment, during the spontaneous breathing trial, and up to about 90 days after extubation. The study will measure outcomes such as weaning failure, pulmonary edema recurrence, and mortality over 90 days. Safety and treatment effects will be closely followed throughout the study period, which runs up to approximately three months post-extubation.
CONDITIONS
Brief Title
SGLT2 Inhibitors in Patients With ADHF During Ventilator Weaning
Who Can Participate
Age: 20Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 20 years or older
- Hospitalized for acute heart failure with reduced ejection fraction (LVEF ≤ 40%)
- Stabilized with systolic blood pressure ≥100 mm Hg and no hypotension symptoms in the past 6 hours
- No increase in intravenous diuretics within 6 hours before randomization
- No intravenous vasodilators, including nitrates, in the 6 hours prior to randomization
- No intravenous inotropic drugs in the 24 hours before randomization
- Elevated NT-proBNP or BNP levels according to atrial fibrillation status
- Intubated and on a ventilator for at least 24 hours with stable oxygen and ventilator settings allowing weaning
You will not qualify if you...
- Decision made to withdraw life support
- Presence of cardiogenic shock
- Heart failure hospitalization triggered by acute myocardial infarction or pulmonary embolism
- Planned or recent cardiovascular revascularization, major cardiac surgery, intervention, or device implantation within 30 days
- Acute coronary syndrome, myocardial infarction, stroke, or transient ischemic attack within 90 days
- Estimated glomerular filtration rate less than 30 ml/min/1.73 m²
- Type 1 diabetes mellitus
- Poorly controlled type 2 diabetes mellitus (HbA1c above 10.5%)
- Uncontrolled urinary tract infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 3 days before ventilator weaning until extubation
Participants are treated with or without SGLT2 inhibitors starting 3 days before ventilator weaning while undergoing a series of examinations to monitor heart function and response.
Multiple visits linked to ventilator weaning and treatment initiation
Follow-up
Duration - Up to 90 days after extubation
Participants are assessed through echocardiography, biomarkers, and clinical evaluations up to 90 days after extubation to monitor outcomes and treatment effects.
Visits at within 24 hours, 7-10 days, and around 90 days after extubation
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
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Research Team
C
Chih Fan Yeh
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Empagliflozin in Heart Failure with a Preserved Ejection Fraction.
Stefan D Anker, Javed Butler, Gerasimos Filippatos...
https://pubmed.ncbi.nlm.nih.gov/34449189The SGLT2 inhibitor canagliflozin in heart failure: the CHIEF-HF remote, patient-centered randomized trial.
John A Spertus, Mary C Birmingham, Michael Nassif...
https://pubmed.ncbi.nlm.nih.gov/35228753Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction.
Scott D Solomon, John J V McMurray, Brian Claggett...
https://pubmed.ncbi.nlm.nih.gov/360275702022 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.
Paul A Heidenreich, Biykem Bozkurt, David Aguilar...
https://pubmed.ncbi.nlm.nih.gov/35379503