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 Status: Recruiting
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Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Participation Requirements View:
Inclusion Criteria
Exclusion Criteria
• Age ≥ 18 years
• Documented diagnosis of symptomatic HF (NYHA functional class II-IV)
• Having had a recent HF event within 6 months (hospitalization or urgent visit)
• Have a LVEF value from an assessment within the last 12 months
• Managed with SoC therapy for HF and renal impairment according to local guidelines
• NT-proBNP must be \>300 pg/mL (\>600 pg/mL if concomitant atrial fibrillation or atrial flutter)
• Not taking an MRA
• An eGFR ≥ 20 to \< 60 mL/min/1.73 m2
• Serum/plasma potassium ≥ 3.5 mmol/L and ≤ 5.0 mmol/L
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WITHDRAWN
Yokohama
Research Site
RECRUITING
Kajang
Research Site
RECRUITING
Kota Kinabalu
Research Site
RECRUITING
Kota Samarahan
Research Site
RECRUITING
Kuala Lumpur
Research Site
RECRUITING
Kuala Terengganu
Research Site
RECRUITING
Kuantan
Research Site
RECRUITING
Sungai Buloh
Research Site
RECRUITING
Aguascalientes
Research Site
RECRUITING
Chihuahua City
Research Site
NOT_YET_RECRUITING
Cuauhtémoc
Research Site
NOT_YET_RECRUITING
Cuauhtémoc
Research Site
RECRUITING
Culiacán
Research Site
RECRUITING
Culiacán
Research Site
NOT_YET_RECRUITING
Guadalajara
Research Site
NOT_YET_RECRUITING
Mazatlán
Research Site
NOT_YET_RECRUITING
Metepec
Research Site
RECRUITING
México
Research Site
NOT_YET_RECRUITING
México
Research Site
SUSPENDED
México
Research Site
WITHDRAWN
Mexico City
Research Site
NOT_YET_RECRUITING
Mexico City
Research Site
NOT_YET_RECRUITING
Monterrey
Research Site
NOT_YET_RECRUITING
Morelia
Research Site
NOT_YET_RECRUITING
Querétaro
Research Site
WITHDRAWN
San Luis Potosí City
Research Site
RECRUITING
Tijuana
Research Site
RECRUITING
Torreón
Research Site
NOT_YET_RECRUITING
Veracruz
Research Site
NOT_YET_RECRUITING
Xalapa
Research Site
RECRUITING
Amsterdam
Research Site
RECRUITING
Arnhem
Research Site
RECRUITING
Emmen
Research Site
RECRUITING
Goes
Research Site
RECRUITING
Hardenberg
Research Site
RECRUITING
Leeuwarden
Research Site
RECRUITING
Bellavista
Research Site
RECRUITING
Lima
Research Site
RECRUITING
Lima
Research Site
RECRUITING
Lima
Research Site
WITHDRAWN
Lima
Research Site
RECRUITING
Lima
Research Site
WITHDRAWN
Lima
Research Site
RECRUITING
Lima
Research Site
NOT_YET_RECRUITING
Lima
Research Site
RECRUITING
Lima
Research Site
RECRUITING
Lima
Research Site
RECRUITING
Piura
Research Site
RECRUITING
Angeles City
Research Site
NOT_YET_RECRUITING
Cebu City
Research Site
WITHDRAWN
Cebu City
Research Site
RECRUITING
City Of Taguig
Research Site
RECRUITING
Davao City
Research Site
NOT_YET_RECRUITING
Davao City
Research Site
RECRUITING
Davao City
Research Site
RECRUITING
Iloilo City
Research Site
RECRUITING
Las Piñas
Research Site
RECRUITING
Mabalacat
Research Site
RECRUITING
Makati
Research Site
RECRUITING
Manadaluyong City
Research Site
WITHDRAWN
Manila
Research Site
RECRUITING
Marikina City
Research Site
RECRUITING
Pasig
Research Site
RECRUITING
Quezon City
Research Site
RECRUITING
Quezon City
Research Site
RECRUITING
Quezon City
Research Site
RECRUITING
Roxas City
Research Site
RECRUITING
West San Juan City
Research Site
RECRUITING
Biała Podlaska
Research Site
WITHDRAWN
Bielsko-biala
Research Site
WITHDRAWN
Bydgoszcz
Research Site
TERMINATED
Bydgoszcz
Research Site
RECRUITING
Chrzanów
Research Site
RECRUITING
Gdansk
Research Site
RECRUITING
Gdansk
Research Site
WITHDRAWN
Gdynia
Research Site
RECRUITING
Katowice
Research Site
RECRUITING
Kazimierza Wielka
Research Site
RECRUITING
Kędzierzyn-koźle
Research Site
WITHDRAWN
Krakow
Research Site
RECRUITING
Krakow
Research Site
RECRUITING
Krakow
Research Site
RECRUITING
Krakow
Research Site
NOT_YET_RECRUITING
Krakow
Research Site
RECRUITING
Lodz
Research Site
WITHDRAWN
Lodz
Research Site
RECRUITING
Lodz
Research Site
RECRUITING
Lodz
Research Site
RECRUITING
Lublin
Research Site
COMPLETED
Lublin
Research Site
RECRUITING
Lublin
Research Site
RECRUITING
Olsztyn
Research Site
RECRUITING
Ostrów Mazowiecka
Research Site
RECRUITING
Piekary Śląskie
Research Site
RECRUITING
Poznan
Research Site
RECRUITING
Poznan
Research Site
RECRUITING
Rzeszów
Research Site
WITHDRAWN
Rzeszów
Research Site
RECRUITING
Szczecin
Research Site
RECRUITING
Tarnów
Research Site
RECRUITING
Torun
Research Site
RECRUITING
Tychy
Research Site
WITHDRAWN
Warsaw
Research Site
WITHDRAWN
Warsaw
Research Site
RECRUITING
Warsaw
Research Site
RECRUITING
Wroclaw
Research Site
WITHDRAWN
Wroclaw
Research Site
RECRUITING
Zabrze
Research Site
RECRUITING
Anyang-si
Research Site
RECRUITING
Bucheon-si
Research Site
RECRUITING
Busan
Research Site
RECRUITING
Busan
Research Site
RECRUITING
Busan
Research Site
RECRUITING
Busan
Research Site
RECRUITING
Cheongju-si
Research Site
RECRUITING
Daegu
Research Site
RECRUITING
Daejeon
Research Site
RECRUITING
Gwangju
Research Site
RECRUITING
Gwangmyeong
Research Site
RECRUITING
Incheon
Research Site
RECRUITING
Junggu
Research Site
RECRUITING
Seongnam-si
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Research Site
SUSPENDED
Seoul
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Uijeongbu-si
Research Site
SUSPENDED
Wŏnju
Research Site
RECRUITING
Yangsan
Research Site
NOT_YET_RECRUITING
Afumaţi
Research Site
NOT_YET_RECRUITING
Arad
Research Site
NOT_YET_RECRUITING
Baia Mare
Research Site
RECRUITING
Brasov
Research Site
NOT_YET_RECRUITING
Brasov
Research Site
TERMINATED
Bucharest
Research Site
RECRUITING
Bucharest
Research Site
RECRUITING
Bucharest
Research Site
NOT_YET_RECRUITING
Bucharest
Research Site
WITHDRAWN
Bucharest
Research Site
TERMINATED
Cluj-napoca
Research Site
RECRUITING
Iași
Research Site
RECRUITING
Iași
Research Site
RECRUITING
Satu Mare
Research Site
RECRUITING
Târgu Mureş
Research Site
RECRUITING
Târgu Mureş
Research Site
TERMINATED
Timișoara
Research Site
RECRUITING
Timișoara
Research Site
NOT_YET_RECRUITING
Dammam
Research Site
RECRUITING
Jeddah
Research Site
RECRUITING
Riyadh
Research Site
RECRUITING
Riyadh
Research Site
RECRUITING
Riyadh
Research Site
RECRUITING
Riyadh
Research Site
RECRUITING
Banská Bystrica
Research Site
RECRUITING
Bratislava
Research Site
NOT_YET_RECRUITING
Bratislava
Research Site
RECRUITING
Brezno
Research Site
RECRUITING
Košice
Research Site
RECRUITING
Košice
Research Site
RECRUITING
Martin
Research Site
RECRUITING
Myjava
Research Site
RECRUITING
Nitra
Research Site
WITHDRAWN
Nové Zámky
Research Site
RECRUITING
Považská Bystrica
Research Site
WITHDRAWN
Prešov
Research Site
NOT_YET_RECRUITING
Rimavská Sobota
Research Site
RECRUITING
Rimavská Sobota
Research Site
RECRUITING
Svidník
Research Site
RECRUITING
Bloemfontein
Research Site
RECRUITING
Centurion
Research Site
RECRUITING
Durban
Research Site
RECRUITING
Johannesburg
Research Site
NOT_YET_RECRUITING
Kwadukuza
Research Site
RECRUITING
Panorama
Research Site
RECRUITING
Parow
Research Site
NOT_YET_RECRUITING
Pietermaritzburg
Research Site
RECRUITING
Somerset West
Research Site
RECRUITING
Soweto
Research Site
RECRUITING
Worcester
Research Site
RECRUITING
A Coruña
Research Site
RECRUITING
Barcelona
Research Site
RECRUITING
Barcelona
Research Site
RECRUITING
Barcelona
Research Site
RECRUITING
Lugo
Research Site
RECRUITING
Madrid
Research Site
RECRUITING
Madrid
Research Site
RECRUITING
Majadahonda
Research Site
RECRUITING
Seville
Research Site
RECRUITING
Seville
Research Site
RECRUITING
Valencia
Research Site
WITHDRAWN
Alingsås
Research Site
RECRUITING
Gothenburg
Research Site
WITHDRAWN
Helsingborg
Research Site
RECRUITING
Jönköping
Research Site
RECRUITING
Karlstad
Research Site
WITHDRAWN
Lund
Research Site
RECRUITING
Mölndal
Research Site
RECRUITING
Stockholm
Research Site
RECRUITING
Stockholm
Research Site
RECRUITING
Stockholm
Research Site
RECRUITING
Uppsala
Research Site
RECRUITING
Västerås
Research Site
RECRUITING
Changhua
Research Site
RECRUITING
Kaohsiung City
Research Site
RECRUITING
Kaohsiung City
Research Site
RECRUITING
New Taipei City
Research Site
RECRUITING
New Taipei City
Research Site
RECRUITING
New Taipei City
Research Site
RECRUITING
Taichung
Research Site
RECRUITING
Taichung
Research Site
NOT_YET_RECRUITING
Taichung
Research Site
RECRUITING
Taipei
Research Site
RECRUITING
Taipei
Research Site
RECRUITING
Taipei
Research Site
RECRUITING
Taipei
Research Site
RECRUITING
Taipei
Research Site
RECRUITING
Taipei
Research Site
RECRUITING
Taipei
Research Site
RECRUITING
Taoyuan District
Research Site
RECRUITING
Yilan
Research Site
RECRUITING
Yung Kang City
Research Site
RECRUITING
Bangkok
Research Site
RECRUITING
Bangkok
Research Site
NOT_YET_RECRUITING
Bangkok
Research Site
RECRUITING
Chiang Mai
Research Site
RECRUITING
Hat Yai
Research Site
RECRUITING
Khon Kaen
Research Site
RECRUITING
Naimuang
Research Site
RECRUITING
Pathum Thani
Research Site
RECRUITING
Adana
Research Site
RECRUITING
Ankara
Research Site
RECRUITING
Antalya
Research Site
RECRUITING
Antalya
Research Site
RECRUITING
Bursa
Research Site
RECRUITING
Dinar
Research Site
RECRUITING
Eskişehir
Research Site
WITHDRAWN
Istanbul
Research Site
RECRUITING
Izmir
Research Site
RECRUITING
Kocaeli
Research Site
RECRUITING
Kütahya
Research Site
RECRUITING
Merkez
Research Site
RECRUITING
Muğla
Research Site
RECRUITING
Sivas
Research Site
RECRUITING
Chernivtsі
Research Site
RECRUITING
Ivano-frankivsk
Research Site
RECRUITING
Kyiv
Research Site
RECRUITING
Kyiv
Research Site
RECRUITING
Kyiv
Research Site
RECRUITING
Kyiv
Research Site
RECRUITING
Kyiv
Research Site
RECRUITING
Kyiv
Research Site
RECRUITING
Ternopil
Research Site
RECRUITING
Ternopil
Research Site
RECRUITING
Uzhhorod
Research Site
RECRUITING
Vinnytsia
Research Site
RECRUITING
Vinnytsia
Research Site
RECRUITING
Zhytomyr
Research Site
RECRUITING
Airdrie
Research Site
RECRUITING
Barnet
Research Site
WITHDRAWN
Cambridge
Research Site
RECRUITING
Clydebank
Research Site
RECRUITING
Exeter
Research Site
RECRUITING
Harefield
Research Site
RECRUITING
Hastings
Research Site
WITHDRAWN
High Wycombe
Research Site
RECRUITING
Kent
Research Site
RECRUITING
Kings Lynn
Research Site
WITHDRAWN
Lincoln
Research Site
WITHDRAWN
London
Research Site
COMPLETED
London
Research Site
RECRUITING
Middlesbrough
Research Site
RECRUITING
Portsmouth
Research Site
RECRUITING
Sheffield
Research Site
RECRUITING
Sunderland
Research Site
RECRUITING
Wakefield
Research Site
RECRUITING
Can Tho
Research Site
RECRUITING
Da Nang
Research Site
RECRUITING
Hà Nội
Research Site
RECRUITING
Haiphong
Research Site
RECRUITING
Hanoi
Research Site
RECRUITING
Hồ Chí Minh
Research Site
RECRUITING
Ho Chi Minh City
Research Site
RECRUITING
Ho Chi Minh City
Research Site
RECRUITING
Hochiminh
Research Site
RECRUITING
Hochiminh City
Research Site
RECRUITING
Huế
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Start Date: 2024-04-12
Estimated Completion Date: 2027-06-11
Target number of participants: 4800
Experimental: balcinrenone/dapagliflozin 15 mg/10 mg
Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
Experimental: balcinrenone/dapagliflozin 40 mg/10 mg
Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
Active_comparator: dapagliflozin 10 mg
Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin