Study to Evaluate the Effect of Balcinrenone/Dapagliflozin 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
AstraZeneca
4,800 participants
Apr 12, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria9
- 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 ≤ 5.0 mmol/L
Exclusion Criteria12
- Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months prior to enrolment or during the screening period
- Major cardiac surgery, coronary revascularisation or valvular repair or replacement, or implantation of a Cardiac resynchronisation therapy device within 3 months prior to enrolment or during the screening period, or planned to undergo any of these operations
- History of hypertrophic obstructive cardiomyopathy
- Complex congenital heart disease or severe uncorrected primary valvular disease
- Symptomatic bradycardia or second- or third-degree heart block without a pacemaker
- Systolic BP \< 90 mmHg, or symptomatic hypotension within the past 24 hours
- Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD or exacerbation of COPD requiring invasive mechanical ventilation assistance within 12 months prior to enrolment
- Type 1 diabetes mellitus
- Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy
- Acute or chronic liver disease with severe impairment of liver function, eg, ascites, oesophageal varices, coagulopathy, and encephalopathy
- Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation for COVID-19 within the last 12 weeks
- Treatment with strong or moderate CYP3A4 inhibitor or inducer
Interventions
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
1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use
Locations(842)
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Beijing, China
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Beijing, China
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Beijing, China
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Beijing, China
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Beijing, China
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Changchun, China
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Changsha, China
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Changsha, China
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Chengdu, China
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Temuco, Chile
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Temuco, Chile
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Valdivia, Chile
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Victoria, Chile
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Baotou, China
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Alexander City, Alabama, United States
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Birmingham, Alabama, United States
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Fairhope, Alabama, United States
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Iloilo City, Philippines
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Las Piñas, Philippines
Research Site
Mabalacat, Philippines
Research Site
Makati, Philippines
Research Site
Manadaluyong City, Philippines
Research Site
Manila, Philippines
Research Site
Marikina City, Philippines
Research Site
Pasig, Philippines
Research Site
Quezon City, Philippines
Research Site
Quezon City, Philippines
Research Site
Quezon City, Philippines
Research Site
Roxas City, Philippines
Research Site
West San Juan City, Philippines
Research Site
Biała Podlaska, Poland
Research Site
Bielsko-Biala, Poland
Research Site
Bydgoszcz, Poland
Research Site
Bydgoszcz, Poland
Research Site
Chrzanów, Poland
Research Site
Gdansk, Poland
Research Site
Gdansk, Poland
Research Site
Gdynia, Poland
Research Site
Katowice, Poland
Research Site
Kazimierza Wielka, Poland
Research Site
Kędzierzyn-Koźle, Poland
Research Site
Krakow, Poland
Research Site
Krakow, Poland
Research Site
Krakow, Poland
Research Site
Krakow, Poland
Research Site
Krakow, Poland
Research Site
Lodz, Poland
Research Site
Lodz, Poland
Research Site
Lodz, Poland
Research Site
Lodz, Poland
Research Site
Lublin, Poland
Research Site
Lublin, Poland
Research Site
Lublin, Poland
Research Site
Olsztyn, Poland
Research Site
Ostrów Mazowiecka, Poland
Research Site
Piekary Śląskie, Poland
Research Site
Poznan, Poland
Research Site
Poznan, Poland
Research Site
Rzeszów, Poland
Research Site
Rzeszów, Poland
Research Site
Szczecin, Poland
Research Site
Tarnów, Poland
Research Site
Torun, Poland
Research Site
Tychy, Poland
Research Site
Warsaw, Poland
Research Site
Warsaw, Poland
Research Site
Warsaw, Poland
Research Site
Wroclaw, Poland
Research Site
Wroclaw, Poland
Research Site
Zabrze, Poland
Research Site
Afumaţi, Romania
Research Site
Arad, Romania
Research Site
Baia Mare, Romania
Research Site
Brasov, Romania
Research Site
Brasov, Romania
Research Site
Bucharest, Romania
Research Site
Bucharest, Romania
Research Site
Bucharest, Romania
Research Site
Bucharest, Romania
Research Site
Bucharest, Romania
Research Site
Cluj-Napoca, Romania
Research Site
Iași, Romania
Research Site
Iași, Romania
Research Site
Satu Mare, Romania
Research Site
Târgu Mureş, Romania
Research Site
Târgu Mureş, Romania
Research Site
Timișoara, Romania
Research Site
Timișoara, Romania
Research Site
Dammam, Saudi Arabia
Research Site
Jeddah, Saudi Arabia
Research Site
Riyadh, Saudi Arabia
Research Site
Riyadh, Saudi Arabia
Research Site
Riyadh, Saudi Arabia
Research Site
Riyadh, Saudi Arabia
Research Site
Riyadh, Saudi Arabia
Research Site
Banská Bystrica, Slovakia
Research Site
Bratislava, Slovakia
Research Site
Bratislava, Slovakia
Research Site
Brezno, Slovakia
Research Site
Košice, Slovakia
Research Site
Košice, Slovakia
Research Site
Martin, Slovakia
Research Site
Myjava, Slovakia
Research Site
Nitra, Slovakia
Research Site
Nové Zámky, Slovakia
Research Site
Považská Bystrica, Slovakia
Research Site
Prešov, Slovakia
Research Site
Rimavská Sobota, Slovakia
Research Site
Rimavská Sobota, Slovakia
Research Site
Svidník, Slovakia
Research Site
Bloemfontein, South Africa
Research Site
Centurion, South Africa
Research Site
Durban, South Africa
Research Site
Johannesburg, South Africa
Research Site
KwaDukuza, South Africa
Research Site
Panorama, South Africa
Research Site
Parow, South Africa
Research Site
Pietermaritzburg, South Africa
Research Site
Somerset West, South Africa
Research Site
Soweto, South Africa
Research Site
Worcester, South Africa
Research Site
Anyang-si, South Korea
Research Site
Bucheon-si, South Korea
Research Site
Busan, South Korea
Research Site
Busan, South Korea
Research Site
Busan, South Korea
Research Site
Busan, South Korea
Research Site
Cheongju-si, South Korea
Research Site
Daegu, South Korea
Research Site
Daejeon, South Korea
Research Site
Gwangju, South Korea
Research Site
Gwangmyeong, South Korea
Research Site
Incheon, South Korea
Research Site
Junggu, South Korea
Research Site
Seongnam-si, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Uijeongbu-si, South Korea
Research Site
Wŏnju, South Korea
Research Site
Yangsan, South Korea
Research Site
A Coruña, Spain
Research Site
Barcelona, Spain
Research Site
Barcelona, Spain
Research Site
Barcelona, Spain
Research Site
Lugo, Spain
Research Site
Madrid, Spain
Research Site
Madrid, Spain
Research Site
Majadahonda, Spain
Research Site
Seville, Spain
Research Site
Seville, Spain
Research Site
Seville, Spain
Research Site
Valencia, Spain
Research Site
Alingsås, Sweden
Research Site
Gothenburg, Sweden
Research Site
Jönköping, Sweden
Research Site
Karlstad, Sweden
Research Site
Mölndal, Sweden
Research Site
Stockholm, Sweden
Research Site
Stockholm, Sweden
Research Site
Stockholm, Sweden
Research Site
Stockholm, Sweden
Research Site
Uppsala, Sweden
Research Site
Västerås, Sweden
Research Site
Changhua, Taiwan
Research Site
Kaohsiung City, Taiwan
Research Site
Kaohsiung City, Taiwan
Research Site
New Taipei City, Taiwan
Research Site
New Taipei City, Taiwan
Research Site
New Taipei City, Taiwan
Research Site
Taichung, Taiwan
Research Site
Taichung, Taiwan
Research Site
Taichung, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taoyuan District, Taiwan
Research Site
Yilan, Taiwan
Research Site
Yung Kang City, Taiwan
Research Site
Bangkok, Thailand
Research Site
Bangkok, Thailand
Research Site
Bangkok, Thailand
Research Site
Chiang Mai, Thailand
Research Site
Hat Yai, Thailand
Research Site
Khon Kaen, Thailand
Research Site
Naimuang, Thailand
Research Site
Pathum Thani, Thailand
Research Site
Adana, Turkey (Türkiye)
Research Site
Ankara, Turkey (Türkiye)
Research Site
Antalya, Turkey (Türkiye)
Research Site
Antalya, Turkey (Türkiye)
Research Site
Bursa, Turkey (Türkiye)
Research Site
Center, Turkey (Türkiye)
Research Site
Dinar, Turkey (Türkiye)
Research Site
Eskişehir, Turkey (Türkiye)
Research Site
Istanbul, Turkey (Türkiye)
Research Site
Izmir, Turkey (Türkiye)
Research Site
Kocaeli, Turkey (Türkiye)
Research Site
Kütahya, Turkey (Türkiye)
Research Site
Muğla, Turkey (Türkiye)
Research Site
Sivas, Turkey (Türkiye)
Research Site
Chernivtsі, Ukraine
Research Site
Ivano-Frankivsk, Ukraine
Research Site
Kyiv, Ukraine
Research Site
Kyiv, Ukraine
Research Site
Kyiv, Ukraine
Research Site
Kyiv, Ukraine
Research Site
Kyiv, Ukraine
Research Site
Kyiv, Ukraine
Research Site
Ternopil, Ukraine
Research Site
Ternopil, Ukraine
Research Site
Uzhhorod, Ukraine
Research Site
Vinnytsia, Ukraine
Research Site
Vinnytsia, Ukraine
Research Site
Zhytomyr, Ukraine
Research Site
Airdrie, United Kingdom
Research Site
Barnet, United Kingdom
Research Site
Cambridge, United Kingdom
Research Site
Clydebank, United Kingdom
Research Site
Exeter, United Kingdom
Research Site
Harefield, United Kingdom
Research Site
Hastings, United Kingdom
Research Site
High Wycombe, United Kingdom
Research Site
Kent, United Kingdom
Research Site
Kings Lynn, United Kingdom
Research Site
Lincoln, United Kingdom
Research Site
London, United Kingdom
Research Site
London, United Kingdom
Research Site
Middlesbrough, United Kingdom
Research Site
Portsmouth, United Kingdom
Research Site
Sheffield, United Kingdom
Research Site
Sunderland, United Kingdom
Research Site
Wakefield, United Kingdom
Research Site
Can Tho, Vietnam
Research Site
Da Nang, Vietnam
Research Site
Haiphong, Vietnam
Research Site
Hanoi, Vietnam
Research Site
Hà Nội, Vietnam
Research Site
Ho Chi Minh City, Vietnam
Research Site
Ho Chi Minh City, Vietnam
Research Site
Hochiminh City, Vietnam
Research Site
Hochiminh, Vietnam
Research Site
Hồ Chí Minh, Vietnam
Research Site
Huế, Vietnam
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NCT06307652