Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
A Phase III, Randomised, Placebo-controlled, Event-driven Study to Evaluate the Effect of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on the Risk of Incident Heart Failure and Cardiovascular Death
AstraZeneca
11,300 participants
Mar 14, 2025
INTERVENTIONAL
Conditions
Summary
Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one additional risk factor for HF. The study will include an optional pre-screening period to facilitate sites' identification of potentially eligible participants to enter the full screening assessments. Participants will not be required to visit the site and no informed consent is required for the optional pre-screening period. The pre-screening assessments do not replace the full screening tests at Visit 1. Upon entering the screening period, all consented participants (after signature of screening ICF) will be screened during an up to 14-day screening period. Participants who meet all screening inclusion/exclusion criteria but are not treated with SGLT2i or are treated for less than 4 weeks will enter a run-in period with dapagliflozin 10 mg once daily for at least 4 weeks (and not more than 6 weeks) before randomisation. Site visits will take place at approximately 2-, 4-, 8-, 16-, and 34-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of the first secondary endpoint events (ie, the composite of hospitalisation for HF or CV death) is predicted to have occurred i.e., the PACD. In case of premature discontinuation of the blinded study intervention, participants will remain in the study. Unless a participant meets the dapagliflozin specific discontinuation criteria, they will continue to receive open label dapagliflozin 10 mg. It is important that the scheduled study visits and data collection continue according to the study protocol.
Eligibility
Inclusion Criteria11
- Participants of any sex and gender must be ≥ 40 years old at the time of signing the informed consent.
- Diagnosed with T2DM and requiring treatment
- Established CV disease (ischaemic heart disease, cerebrovascular disease, peripheral arterial disease)
- History of HTN and an SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the Randomisation Visit.
- At least one additional risk factor for HF:
- Age ≥ 70 years
- UACR \> 20 mg/g
- eGFR \< 60 mL/min/1.73 m2
- History of polyvascular disease (at least two of: ischaemic heart disease, cerebrovascular disease, and peripheral arterial disease)
- History of atrial fibrillation or atrial flutter
- NT-proBNP \> 125 ng/L
Exclusion Criteria13
- Previously confirmed diagnosis and treatment of heart failure
- An eGFR \< 30 mL/min/1.73 m2 at screening
- Known hyperkalaemia, defined as potassium ≥ 5.5 mmol/L within 3 months prior to screening
- Type 1 diabetes mellitus or uncontrolled T2DM with HbA1c \> 10.5% (\> 91 mmol/mol) at screening
- Serum sodium \< 135 mmol/L at screening, determined as per central laboratory assessment
- Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, carotid angioplasty, or cardiac surgery, within 3 months prior to randomisation
- Myocardial infarction within 3 months prior to randomisation, or within 1 month prior to randomisation when there is no further planned revascularisation
- Percutaneous coronary intervention within 1 month prior to randomisation
- Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history
- Documented history of adrenal insufficiency
- Any dialysis (including for acute kidney injury) within 3 months prior to screening
- Any acute kidney injury within 3 months prior to screening
- Prohibited concomitant medications
Interventions
baxdrostat tablet and dapagliflozin tablet
placebo tablet and dapagliflozin tablet
Locations(917)
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Pleven, Bulgaria
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Birmingham, Alabama, United States
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Nagano, Japan
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Ogaki-shi, Japan
Research Site
Osaka, Japan
Research Site
Osaka, Japan
Research Site
Osaka, Japan
Research Site
Osaka, Japan
Research Site
Ōita, Japan
Research Site
Ōmihachiman, Japan
Research Site
Saitama-shi, Japan
Research Site
Sendai, Japan
Research Site
Sendai, Japan
Research Site
Shizuoka, Japan
Research Site
Suita-shi, Japan
Research Site
tabashi City, Japan
Research Site
Takamatsu, Japan
Research Site
Takatsuki-shi, Japan
Research Site
Toyota-Shi, Japan
Research Site
Tsuchiura-shi, Japan
Research Site
Ueda-shi, Japan
Research Site
Uwajima-shi, Japan
Research Site
Yanagawa-shi, Japan
Research Site
Yokkaichi-shi, Japan
Research Site
Yokohama, Japan
Research Site
Alor Star, Malaysia
Research Site
Johor Bahru, Malaysia
Research Site
Kota Samarahan, Malaysia
Research Site
Kuala Terengganu, Malaysia
Research Site
Kuantan, Malaysia
Research Site
Kuching, Malaysia
Research Site
Malacca, Malaysia
Research Site
Rawang, Malaysia
Research Site
Sarawak Miri, Malaysia
Research Site
Seri Manjung, Malaysia
Research Site
Sungai Buloh, Malaysia
Research Site
Acapulco, Mexico
Research Site
Aguascalientes, Mexico
Research Site
Cuauhtémoc, Mexico
Research Site
Cuernavaca, Mexico
Research Site
Culiacán, Mexico
Research Site
Culiacán, Mexico
Research Site
Durango, Mexico
Research Site
Guadalajara, Mexico
Research Site
Guadalajara, Mexico
Research Site
Mexico City, Mexico
Research Site
Monterrey, Mexico
Research Site
Querétaro City, Mexico
Research Site
San Juan del Río, Mexico
Research Site
Veracruz, Mexico
Research Site
Xalapa, Mexico
Research Site
Xalapa, Mexico
Research Site
Zapopan, Mexico
Research Site
's-Hertogenbosch, Netherlands
Research Site
Almelo, Netherlands
Research Site
Amsterdam, Netherlands
Research Site
Amsterdam, Netherlands
Research Site
Born, Netherlands
Research Site
Deventer, Netherlands
Research Site
Ede, Netherlands
Research Site
Enschede, Netherlands
Research Site
Haarlem, Netherlands
Research Site
Harderwijk, Netherlands
Research Site
Hoogeveen, Netherlands
Research Site
Nijmegen, Netherlands
Research Site
Roosendaal, Netherlands
Research Site
Rotterdam, Netherlands
Research Site
Rotterdam, Netherlands
Research Site
Venlo, Netherlands
Research Site
Zwolle, Netherlands
Research Site
Bellavista, Peru
Research Site
Chorrillos, Peru
Research Site
Cusco, Peru
Research Site
Lima, Peru
Research Site
Lima, Peru
Research Site
Lima, Peru
Research Site
Lima, Peru
Research Site
Lima, Peru
Research Site
Lima, Peru
Research Site
Lima, Peru
Research Site
Lima, Peru
Research Site
Lima, Peru
Research Site
Lima, Peru
Research Site
Lima, Peru
Research Site
Lima, Peru
Research Site
Piura, Peru
Research Site
Angeles City, Philippines
Research Site
Cebu, Philippines
Research Site
Davao City, Philippines
Research Site
Davao City, Philippines
Research Site
Fuente Osmena Cebu City, Philippines
Research Site
Iloilo City, Philippines
Research Site
Las Piñas, Philippines
Research Site
Lipa City, Philippines
Research Site
Manadaluyong City, Philippines
Research Site
Puerto Princesa City, Philippines
Research Site
Quezon City, Philippines
Research Site
Roxas City, Philippines
Research Site
Bialystok, Poland
Research Site
Biała Podlaska, Poland
Research Site
Bydgoszcz, Poland
Research Site
Chojnice, Poland
Research Site
Chojnice, Poland
Research Site
Chrzanów, Poland
Research Site
Częstochowa, Poland
Research Site
Gdansk, Poland
Research Site
Gdansk, Poland
Research Site
Gdynia, Poland
Research Site
Gdynia, Poland
Research Site
Jasło, Poland
Research Site
Katowice, Poland
Research Site
Katowice, Poland
Research Site
Katowice, Poland
Research Site
Katowice, Poland
Research Site
Katowice, Poland
Research Site
Katowice, Poland
Research Site
Krakow, Poland
Research Site
Krakow, Poland
Research Site
Lodz, Poland
Research Site
Lodz, Poland
Research Site
Lublin, Poland
Research Site
Lublin, Poland
Research Site
Lublin, Poland
Research Site
Lublin, Poland
Research Site
Myszków, 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
Poznan, Poland
Research Site
Poznan, Poland
Research Site
Przemyśl, Poland
Research Site
Płock, Poland
Research Site
Radzionków, Poland
Research Site
Rzeszów, Poland
Research Site
Skórzewo, Poland
Research Site
Szczecin, Poland
Research Site
Szczecin, Poland
Research Site
Tarnów, Poland
Research Site
Torun, Poland
Research Site
Warsaw, Poland
Research Site
Warsaw, Poland
Research Site
Warsaw, Poland
Research Site
Warsaw, Poland
Research Site
Warsaw, Poland
Research Site
Warsaw, Poland
Research Site
Warsaw, Poland
Research Site
Wroclaw, Poland
Research Site
Zabrze, Poland
Research Site
Bacau, Romania
Research Site
Baia Mare, Romania
Research Site
Baia Mare, 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
Bucharest, Romania
Research Site
Craiova, Romania
Research Site
Iași, Romania
Research Site
Ploieşti, Romania
Research Site
Satu Mare, Romania
Research Site
Târgu Mureş, Romania
Research Site
Bratislava, Slovakia
Research Site
Bratislava, Slovakia
Research Site
Bratislava, Slovakia
Research Site
Brezno, Slovakia
Research Site
Handlová, Slovakia
Research Site
Košice, Slovakia
Research Site
Košice, Slovakia
Research Site
Lučenec, Slovakia
Research Site
Ľubochňa, Slovakia
Research Site
Malacky, Slovakia
Research Site
Námestovo, Slovakia
Research Site
Prešov, Slovakia
Research Site
Prievidza, Slovakia
Research Site
Rimavská Sobota, Slovakia
Research Site
Rožňava, Slovakia
Research Site
Sabinov, Slovakia
Research Site
Svidník, Slovakia
Research Site
Bellville, South Africa
Research Site
Benoni, South Africa
Research Site
Brackenfell, South Africa
Research Site
Cape Town, South Africa
Research Site
Cape Town, South Africa
Research Site
Centurion, South Africa
Research Site
Claremont, South Africa
Research Site
Diepkloof, Soweto, South Africa
Research Site
Durban, South Africa
Research Site
Durban, South Africa
Research Site
East London, South Africa
Research Site
eMkhomazi, South Africa
Research Site
Extension 8, Lenasia, South Africa
Research Site
Lenasia, South Africa
Research Site
Midrand, South Africa
Research Site
Paarl, South Africa
Research Site
Pretoria, South Africa
Research Site
Pretoria, South Africa
Research Site
Somerset West, South Africa
Research Site
Wentworth, South Africa
Research Site
Worcester, South Africa
Research Site
Bucheon-si, South Korea
Research Site
Cheongju-si, South Korea
Research Site
Daegu, 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
Suwon, 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
Córdoba, Spain
Research Site
Córdoba, Spain
Research Site
L'Hospitalet de Llobregat, Spain
Research Site
Madrid, Spain
Research Site
Málaga, Spain
Research Site
Sant Joan Despí, Spain
Research Site
Santiago(A Coruña), Spain
Research Site
Seville, Spain
Research Site
Seville, Spain
Research Site
Valencia, Spain
Research Site
Vigo, Spain
Research Site
Gothenburg, Sweden
Research Site
Helsingborg, Sweden
Research Site
Huddinge, Sweden
Research Site
Lund, Sweden
Research Site
Lund, Sweden
Research Site
Mölndal, Sweden
Research Site
Norrköping, Sweden
Research Site
Stockholm, Sweden
Research Site
Stockholm, Sweden
Research Site
Stockholm, Sweden
Research Site
Uppsala, Sweden
Research Site
Uppsala, Sweden
Research Site
Changhua, Taiwan
Research Site
Hsinchu, Taiwan
Research Site
Hualien City, Taiwan
Research Site
Kaohsiung City, Taiwan
Research Site
New Taipei City, Taiwan
Research Site
Taichung, Taiwan
Research Site
Taichung, Taiwan
Research Site
Taichung, Taiwan
Research Site
Taichung, Taiwan
Research Site
Tainan, 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
Bangkok, Thailand
Research Site
Bangkok, Thailand
Research Site
Banphaeo, Thailand
Research Site
Bansuan, Muang, Chonburi, Thailand
Research Site
Chiang Mai, Thailand
Research Site
Dusit, Thailand
Research Site
Hat Yai, Thailand
Research Site
Khlong Luang, Thailand
Research Site
Khon Kaen, Thailand
Research Site
Muang, Thailand
Research Site
Naimuang, Thailand
Research Site
Ubonratchathani, Thailand
Research Site
Adana, Turkey (Türkiye)
Research Site
Afyonkarahisar, Turkey (Türkiye)
Research Site
Ankara, Turkey (Türkiye)
Research Site
Antalya, Turkey (Türkiye)
Research Site
Eskişehir, Turkey (Türkiye)
Research Site
Istanbul, Turkey (Türkiye)
Research Site
Istanbul, Turkey (Türkiye)
Research Site
Izmir, Turkey (Türkiye)
Research Site
Kahramanmaraş, Turkey (Türkiye)
Research Site
Kocaeli, Turkey (Türkiye)
Research Site
Kütahya, Turkey (Türkiye)
Research Site
Malatya, Turkey (Türkiye)
Research Site
Samsun, 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
Aberdeen, United Kingdom
Research Site
Chesterfield, United Kingdom
Research Site
Dundee, United Kingdom
Research Site
Gatley, United Kingdom
Research Site
Glasgow, United Kingdom
Research Site
Glasgow, United Kingdom
Research Site
London, United Kingdom
Research Site
Norwich, United Kingdom
Research Site
Penzance, United Kingdom
Research Site
Redruth, United Kingdom
Research Site
Sandbach, United Kingdom
Research Site
Southampton, United Kingdom
Research Site
Stockton-on-Tees, United Kingdom
Research Site
Swansea, United Kingdom
Research Site
Weston-super-Mare, United Kingdom
Research Site
Wolverhampton, United Kingdom
Research Site
Woodbridge, United Kingdom
Research Site
Yate, United Kingdom
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
Ho Chi Minh City, Vietnam
Research Site
Huế, Vietnam
Research Site
Rach Gia, Vietnam
Research Site
Vĩnh Yên, Vietnam
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NCT06677060