This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.
The purpose of this study is to investigate the effect of balcinrenone/dapagliflozin compared with dapagliflozin, on the risk of CV death, HF event with and without hospitalisation, in patients with chronic HF, impaired kidney function, and who have had a recent HF event. Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments: 1. Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 2. Balcinrenone/dapagliflozin 40 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 3. Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule The study is event driven, and the average study duration for a participant is estimated to be 22 months including screening period, 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin. The study will be conducted at approximately 700 sites in approximately 40 countries globally.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
4,800
1 capsule of balcinrenone/dapagliflozin 15 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
1 capsule of balcinrenone/dapagliflozin 40 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation
To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death and HF events with and without hospitalisation
Time frame: Approximately 38 months
Total occurrences (first and recurrent) of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation
To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the rate of total occurrences of CV death, and HF events with and without hospitalisation
Time frame: Approximately 38 months
Total occurrences (first and recurrent) of HF hospitalisations
To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the rate of total HF hospitalisations
Time frame: Approximately 38 months
Time to CV death
To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death
Time frame: Approximately 38 months
The hierarchical composite endpoint of death from any cause, total HF events, and change from baseline in KCCQ total symptom score to 24-week post-randomisation
To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of death from any cause, HF events, and improving patient reported symptoms of HF
Time frame: Approximately 24 weeks
Time to death from any cause
To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of death from any cause
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1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use
Research Site
Alexander City, Alabama, United States
RECRUITINGResearch Site
Birmingham, Alabama, United States
WITHDRAWNResearch Site
Fairhope, Alabama, United States
RECRUITINGResearch Site
Huntsville, Alabama, United States
RECRUITINGResearch Site
Phoenix, Arizona, United States
RECRUITINGResearch Site
Phoenix, Arizona, United States
NOT_YET_RECRUITINGResearch Site
Little Rock, Arkansas, United States
RECRUITINGResearch Site
Beverly Hills, California, United States
RECRUITINGResearch Site
Covina, California, United States
RECRUITINGResearch Site
Encinitas, California, United States
RECRUITING...and 824 more locations
Time frame: Approximately 38 months