Using Empagliflozin and Dapagliflozin for Patients with Acute Heart Failure
Empagliflozin and Dapagliflozin in Patients Hospitalized for Acute Decompensated Heart Failure (EMPATHY) - a Phase III Trial.
This study is testing whether two heart medications, Empagliflozin and Dapagliflozin, can help people who are in the hospital for sudden heart failure feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1364 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Warsaw Academic / other |
| Locations | 1 site (Grodzisk Mazowiecki) |
| Trial ID | NCT05776043 on ClinicalTrials.gov |
What this trial studies
This Phase III clinical trial investigates the effects of SGLT-2 inhibitors, specifically Empagliflozin and Dapagliflozin, on patients hospitalized for acute decompensated heart failure. The study is designed as a national, multicenter, randomized, double-blind, placebo-controlled trial, aiming to assess clinical outcomes in this patient population. Participants will be randomized to receive either the active medication or a placebo, with eligibility criteria focusing on those currently experiencing symptoms of heart failure. The trial will stratify participants based on the type of SGLT-2 inhibitor used.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are hospitalized for acute decompensated heart failure, regardless of their ejection fraction or diabetes status.
Not a fit: Patients who are not currently hospitalized or those who have recently received intensive heart failure treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new treatment options that improve outcomes for patients with acute decompensated heart failure.
How similar studies have performed: Previous studies involving SGLT-2 inhibitors have shown promising results in heart failure management, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients 18 years of age with the capacity to provide written informed consent * Currently hospitalized for a primary diagnosis of acute/decompensated HF (HFrEF, HFmrEF,HFpEF), including symptoms and signs of fluid overload regardless of ejection fraction or diabetes status * In patients with HFpEF the diagnosis has to be confirmed according to the current HFpEF definition (by non-invasive testing: evidence of structural or functional changes in the heart as evidenced on echocardiography or by invasive testing as LVEDP assessment or right heart catheterisation). * Randomized no earlier than 24 hours and up to 10 days after initial presentation while still hospitalized * Stable as defined by: systolic blood pressure (SBP\>100 mmHg for the preceding 6 hours) * No intensification of IV diuretics within the last 6 hours, * No use of IV vasodilators within the last 6 hours, * No use of IV inotropes or levosimendan within the last 24 hours prior to randomization * Elevated NT-proBNP \>600 pg/mL during the current hospitalization in patients with HFrEF and \>300 pg/mL in patients with HFmrEF or HFpEF (or above 900 pg/ml if atrial fibrillation is present at admission independently from EF). * eGFR \>20 ml/min/1,73m2 Exclusion Criteria: * History of ketoacidosis * Type 1 diabetes * SGLT-2 Inhibitor at baseline or known allergy to SGLT-2 Inhibitors * Current active cancer with less than 2 years of life expectancy * Pulmonary embolism, cerebrovascular accident as the primary trigger for the current hospitalization * Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), hypertrophic obstructive cardiomyopathy or known pericardial constriction * Any severe (obstructive or regurgitant) valvular heart disease, expected to lead to surgery during the trial period * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant * Blood pH\<7.32 * \>1 episode of severe hypoglycaemia within the last 6 months under treatment with insulin or sulfonylurea * Acute symptomatic urinary tract infection or genital infection
Where this trial is running
Grodzisk Mazowiecki
- Autonomous Public Specialist Western John Paul II Hospital — Grodzisk Mazowiecki, Poland (Recruiting)
Study contacts
- Study coordinator: Prof. Marek Postula, MD PhD
- Email: mpostula@wum.edu.pl
- Phone: 0048 22 1166160
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.