Empagliflozin for New On-set Heart Failure Study Regardless of Ejection Fraction

Launched by CHINESE UNIVERSITY OF HONG KONG · Sep 22, 2022

Keywords

ClinConnect Summary

The Empagliflozin for New-Onset Heart Failure Study is a clinical trial designed to investigate whether starting a medication called empagliflozin during hospitalization can help patients who are experiencing new heart failure, regardless of how well their heart is pumping blood (known as ejection fraction). Heart failure is a serious condition that often leads to hospital stays, and many patients struggle with readmissions and health complications after they leave the hospital. This trial aims to determine if empagliflozin can safely improve outcomes for these patients over a follow-up period of up to 90 days.

To be eligible for the trial, participants must be at least 18 years old and currently hospitalized for heart failure, presenting with symptoms like shortness of breath and certain clinical signs that indicate heart congestion. Patients with severe heart conditions, recent major cardiac procedures, or specific kidney issues, among other criteria, are excluded from the study. Those who join the trial will have the opportunity to receive empagliflozin while in the hospital and will be monitored for any effects the medication may have on their recovery and overall health. This study is important because it explores a treatment option for a group of heart failure patients who have not been extensively studied before.

Gender

ALL

Eligibility 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.