A Phase III, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared With Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients With Heart Failure and Impaired Kidney Function
A Phase III, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared With Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients With Heart Failure and Impaired Kidney Function
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:
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.
Inclusion Criteria:
Exclusion Criteria:
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CABA, C1425HFA, Argentina
Ciudad de Buenos Aires, 1425DES, Argentina
Ciudad de Buenos Aires, C1419AHL, Argentina
Saint Stefan/Stainz, 8511, Austria
North York, Ontario M6B 3H7, Canada
Region Metropolitana, 7550000, Chile
Plzen - Bory, 305 99, Czechia
Ustí Nad Labem, 40011, Czechia
Dragana, 68100, Greece
Heraklio, 71110, Greece
Beppu-shi, 874-0011, Japan
Fujisawa-shi, 251-8550, Japan
Fukutsu-shi, 811-3298, Japan
Hakusan-shi, 924-8588, Japan
Higashiibaraki-gun, 311-3193, Japan
Iwakuni-shi, 740-8510, Japan
Kanonji-shi, 769-1695, Japan
Kasuga-shi, 816-0864, Japan
Kasugai-shi, 486-8510, Japan
Kawanishi-shi, 666-0125, Japan
Kishiwada-shi, 596-8522, Japan
Kitakyusyu-shi, 806-8501, Japan
Kure-shi, 737-8505, Japan
Matsumoto-shi, 390-8621, Japan
Meguro-ku, 152-8902, Japan
Moriyama-shi, 524-8524, Japan
Sagamihara-shi, 252-5188, Japan
Saitama Shi, 336 8522, Japan
Saitama-shi, 339-0033, Japan
Sanyoonoda-shi, 756-0095, Japan
Toshima-ku, 171-0014, Japan
Tsuchiura-shi, 300-0028, Japan
Ueda-shi, 386-8610, Japan
Uji-shi, 611-0041, Japan
Uwajima-shi, 798-8510, Japan
Yanagawa-shi, 832-0077, Japan
Manadaluyong City, 1552, Philippines
West San Juan City, 1502, Philippines
Yung Kang City, 71044, Taiwan
Naimuang, 30000, Thailand
Chernivtsі, 58002, Ukraine
Hochiminh City, 700000, Vietnam
Hochiminh, 70000, Vietnam
Hồ Chí Minh, 700000, Vietnam