Combination therapy of finerenone plus empagliflozin will be compared to usual care to determine the efficacy and safety of treatment in patients hospitalized with heart failure.
This is an international, randomized, controlled, open-label, trial of an early, intensive management strategy using the combination of finerenone plus sodium-glucose co-transporter 2 inhibitor (SGLT2i) compared with usual care in patients hospitalized with heart failure (HF).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,500
Oral finerenone.
Oral empagliflozin.
Clinical benefit
Hierarchical composite of the following: * Time to all-cause mortality * Number of total HF events * Time to first HF event * Difference of 5 points or greater on the Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS) assessed by the win-ratio method
Time frame: 6 months
Number of serious adverse events (AEs).
\- Serious AEs (excluding efficacy endpoints).
Time frame: 6 months
Number of adverse events leading to discontinuation of study drug.
\- AEs leading to discontinuation of finerenone or empagliflozin.
Time frame: 6 months
Time to first death from any cause or HF event.
Time to first occurrence of all-cause mortality or HF event (hospitalization for HF or urgent visit due to HF)
Time frame: 6 months
Mean change from baseline to 6 months in the Total Symptom Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS).
Time frame: 6 months
Number of HF events from baseline to Day 90.
\- Total (first and recurrent) HF events.
Time frame: 90 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CON-10004 Fairhope, AL Investigational Site
Fairhope, Alabama, United States
RECRUITINGPhoenix, AZ Investigative Site CON-10115
Phoenix, Arizona, United States
RECRUITINGChula Vista, CA Investigative Site CON-10111
Chula Vista, California, United States
RECRUITINGCON-10075 El Centro, CA Investigational Site
El Centro, California, United States
RECRUITINGCON-10024 Sacramento, CA Investigational Site
Sacramento, California, United States
RECRUITINGSan Francisco, CA Investigative Site CON-10315
San Francisco, California, United States
RECRUITINGCON-10023, San Francisco, CA
San Francisco, California, United States
RECRUITINGCON-10109, Van Nuys, CA
Van Nuys, California, United States
RECRUITINGCON-10001, Aurora, CO
Aurora, Colorado, United States
RECRUITINGCON-10005, Denver, CO
Denver, Colorado, United States
RECRUITING...and 130 more locations