Empagliflozin and Dapagliflozin in Patients Hospitalized for Acute Decompensated Heart Failure
Phase 3
Recruiting
- Conditions
- Acute Decompensated Heart Failure
- Interventions
- Registration Number
- NCT05776043
- Lead Sponsor
- Medical University of Warsaw
- Brief Summary
National, multicenter, randomized, double-blind, parallel-group, stratified by SGLT-2 inhibitor type, placebo-controlled trial, - a Phase III study. Primary objective of the study is to investigate the impact of SGLT-2 inhibitors (Empagliflozin and Dapagliflozin) on clinical endpoints in patients hospitalized with acute/decompensated HF.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1364
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SGLT 2 Inhibitor Dapagliflozin 10 MG Empagliflozin (n=341) or Dapagliflozin (n=341): 9 months of treatment Placebo with a switch to SGLT 2 Inhibitor Placebo Placebo (n=682) for 3 months of treatment with a subsequent switch to Empagliflozin (n=341) or Dapagliflozin (n=341): 6 months of treatment SGLT 2 Inhibitor Empagliflozin 10 MG Empagliflozin (n=341) or Dapagliflozin (n=341): 9 months of treatment
- Primary Outcome Measures
Name Time Method Time to first event of adjudicated cardiovascular (CV) death, or adjudicated hospitalization for heart failure in patients with heart failure with reduced ejection fraction (HFrEF) at 3 and 9 months combined endpoint
- Secondary Outcome Measures
Name Time Method Time to adjudicated CV death at 3 and 9 months CV death
Time to adjudicated all cause death at 3 and 9 months all cause death
Time to adjudicated myocardial infarction at 3 and 9 months myocardial infarction
Difference in the number of hospitalizations for other than CV causes between the treatment groups at 3 and 9 months hospitalizations for other than CV causes
Difference in the number of recurrent hospitalizations due to heart failure between the treatment groups at 3 and 9 months recurrent hospitalizations due to heart failure
Difference in the number of hospitalizations for CV causes between the treatment groups at 3 and 9 months hospitalizations for CV causes
eGFR (Estimated Glomerular Filtration Rate) (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Equation)) creatine slope of change from baseline between the treatment groups at 3 and 9 months eGFR
Difference in the number of hospital re-admissions due to heart failure between the treatment groups at 3 and 9 months hospital re-admissions due to heart failure
Difference in the number of hospital re-admissions for any cause between the treatment groups at 3 and 9 months hospital re-admissions for any cause
Difference in the duration of hospital stay between the treatment groups after initiation of the study treatment at 3 and 9 months duration of hospital stay
Difference in the number of incidences of new onset AF and re-occurrence of AF between treatment groups at 3 and 9 months new onset AF
Difference in the change of ejection fraction in echocardiography between treatment groups at 3 and 9 months ejection fraction
Difference in the change of left ventricular diastolic function in echocardiography at 3 and 9 months left ventricular diastolic function
Difference in the change of LV strain analysis in echocardiography at 3 and 9 months LV strain
The time-averaged proportional change in NT-proBNP from at 3 and 9 months NT-proBNP
The time-averaged proportional change in selected miRNA expression linked to hypertrophy, inflammation, fibrosis, apoptosis, electric stability between treatment groups and placebo group at 3 and 9 months miRNA expression
The time-averaged proportional change in pre-specified biomarkers at 3 and 9 months biomarkers
Change from baseline in clinical summary score (HF (Chronic Heart Failure) symptoms and physical limitations domains) of the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 3 and 9 months HF score
Trial Locations
- Locations (1)
Autonomous Public Specialist Western John Paul II Hospital
šµš±Grodzisk Mazowiecki, Poland