Using empagliflozin to treat new-onset heart failure
In-hospital Initiation of Empagliflozin for the Treatment of New-onset Acute Heart Failure Regardless of Ejection Fraction: A Pilot Study
This study is testing whether starting a medication called empagliflozin right after being hospitalized for new heart failure can help improve recovery and reduce the chances of coming back to the hospital.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Shatin) |
| Trial ID | NCT05556044 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of empagliflozin, an SGLT2 inhibitor, in patients hospitalized for acute heart failure, regardless of their ejection fraction. The study aims to determine the optimal timing for initiating this therapy in patients experiencing new-onset heart failure. Participants must meet specific criteria related to their symptoms and laboratory results during hospitalization. The trial seeks to address the high rates of readmission and mortality associated with heart failure.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who are hospitalized for acute heart failure with specific symptoms and laboratory findings.
Not a fit: Patients experiencing cardiogenic shock will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce hospital readmissions and improve survival rates for patients with acute heart failure.
How similar studies have performed: Previous studies have shown that SGLT2 inhibitors can be effective in heart failure patients, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject age \>18 hospitalized for primary diagnosis of acute HF * Dyspnoea (exertional or at rest) and 2 of the following signs: Congestion on chest X-ray; Rales on chest auscultation; Clinically relevant oedema (e.g. ≥1+ on a 0 to 3+ scale); Elevated jugular venous pressure * Stabilization criteria (while in the hospital): systolic blood pressure ≥100mmHg and no symptoms of hypotension in the preceding 24 hours; No increase in i.v. diuretic dose for 24 h prior; No i.v. vasodilators including nitrates within the last 24 h prior; No i.v. inotropic drugs for 24 h prior * NT-proBNP ≥1600 pg/mL or BNP ≥400 pg/mL. (Patients with atrial fibrillation: NT-proBNP ≥2400 pg/mL or BNP ≥600 pg/mL. Measured during index hospitalization * Heart failure hospitalization that requires the treatment of a minimum single dose of 40 mg of i.v. furosemide( or Equivalent i.v loop diuretics defined as 20 mg of torsemide or 1mg of bumetanide) Exclusion Criteria: * Cardiogenic shock * Documented history of HF with previous HF admission * Current hospitalization for acute HF primarily triggered by pulmonary embolism, cerebrovascular accident, or acute myocardial infraction * Interventions in the past 30 days prior or planned during the study: Major cardiac surgery, or Transcatheter aortic valve implantation (TAVI), or percutaneous coronary intervention (PCI), or MitraClip; Implantation of cardiac resynchronization therapy device; Cardiac mechanical support implantation * Current or expected heart transplant, left ventricular assist device (LVAD), intraaortic balloon pumping (IABP), or patients with planned inotropic support in an outpatient setting * Haemodynamically severe uncorrected primary cardiac valvular disease planned for surgery or intervention during the course of the study * eGFR \<20 mL/min/1.73m2 as measured during index hospitalization (latest measurement before randomization) or patients requiring dialysis * Type 1 diabetes mellitus (DM) * History of ketoacidosis, including diabetic ketoacidosis * Current or prior treatment with SGLT2 inhibitors in the 90 days prior to enrolment.
Where this trial is running
Shatin
- The Chinese University of Hong Kong — Shatin, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Bryan Yan — Chinese University of Hong Kong
- Study coordinator: Daniel Xu
- Email: danielxu@cuhk.edu.hk
- Phone: 35051518
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.