Clinical trial NCT06677060: Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Heart Failure
Keywords: Heart failure: Baxdrostat; Dapagliflozin; cardiovascular
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-11-06
Enrollment: 11300
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 criteria: Inclusion Criteria:

1. Participants of any sex and gender must be ≥ 40 years old at the time of signing the informed consent.
2. Diagnosed with T2DM and requiring treatment
3. Established CV disease (ischaemic heart disease, cerebrovascular disease, peripheral arterial disease)
4. History of HTN and an SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the Randomisation Visit.
5. Central laboratory serum potassium must meet the following criteria at the Screening

   Visit, based on screening eGFR:
   * for participants with screening eGFR ≥ 45 mL/min/1.73 m2, potassium must be

     ≥ 3.0 and ≤ 4.8 mmol/L at the Screening Visit
   * for participants with screening eGFR \< 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.5 mmol/L at the Screening Visit
6. 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 Criteria:

1. Previously confirmed diagnosis and treatment of heart failure
2. An eGFR \< 30 mL/min/1.73 m2 at screening
3. Known hyperkalaemia, defined as potassium ≥ 5.5 mmol/L within 3 months prior to screening
4. Type 1 diabetes mellitus or uncontrolled T2DM with HbA1c \> 10.5% (\> 91 mmol/mol) at screening
5. Serum sodium \< 135 mmol/L at screening, determined as per central laboratory assessment
6. Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, carotid angioplasty, or cardiac surgery, within 3 months prior to randomisation
7. Myocardial infarction within 3 months prior to randomisation, or within 1 month prior to randomisation when there is no further planned revascularisation
8. Percutaneous coronary intervention within 1 month prior to randomisation
9. Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history
10. Documented history of adrenal insufficiency
11. Any dialysis (including for acute kidney injury) within 3 months prior to screening
12. Any acute kidney injury within 3 months prior to screening
13. History or known allergy/hypersensitivity to the study treatment, as judged by the Investigator (eg, SGLT2i or active substance or excipients)
14. History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant)
15. Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to screening)
16. Drug or alcohol abuse that in the Investigator's judgement makes the participant a poor candidate for the study
17. Any use of mineralocorticoid receptor antagonists (such as spironolactone, eplerenone, or finerenone) or aldosterone synthase inhibitor within 4 weeks prior to screening and/or during the study
18. Concomitant therapy with strong inducers of cytochrome P450
19. Use of potassium-sparing diuretics (such as triamterene or amiloride) and direct renin inhibitor (eg, aliskiren) at the time of screening
20. Use of potassium binders (such as sodium zirconium cyclosilicate, patiromer, or sodium polystyrene sulfonate) within 4 weeks prior to screening

Primary outcomes:
measure: To determine if baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of an HF event or CV death
timeFrame: Event driven; Up to 38 months
Secondary outcomes:
measure: To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of hospitalisation for HF or CV death
timeFrame: Event driven; Up to 38 months
measure: To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of HF events
timeFrame: Event driven; Up to 38 months
measure: To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of CV death
timeFrame: Event driven; Up to 38 months
measure: To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of all-cause mortality
timeFrame: Event driven; Up to 38 months
measure: To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of stroke or CV death
timeFrame: Event driven; Up to 38 months
measure: To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of atrial fibrillation or CV death in participants without history of atrial fibrillation at baseline
timeFrame: Event driven; Up to 38 months
measure: To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of MI or CV death
timeFrame: Event driven; Up to 38 months
Other outcomes:
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city: Stockholm
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Changhua
country: Taiwan
facility: Research Site
city: Hsinchu
country: Taiwan
facility: Research Site
city: Hualien City
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: New Taipei
country: Taiwan
facility: Research Site
city: Taichung City
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei City
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taoyuan
country: Taiwan
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Banphaeo
country: Thailand
facility: Research Site
city: Bansuan, Muang, Chonburi
country: Thailand
facility: Research Site
city: Chiang Mai
country: Thailand
facility: Research Site
city: Dusit
country: Thailand
facility: Research Site
city: Hat Yai
country: Thailand
facility: Research Site
city: Khlong Luang
country: Thailand
facility: Research Site
city: Khon Kaen
country: Thailand
facility: Research Site
city: Muang
country: Thailand
facility: Research Site
city: Naimuang
country: Thailand
facility: Research Site
city: Ubonratchathani
country: Thailand
facility: Research Site
city: Adana
country: Turkey
facility: Research Site
city: Afyonkarahisar
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Antalya
country: Turkey
facility: Research Site
city: Eskisehir
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Kahramanmaras
country: Turkey
facility: Research Site
city: Kocaeli
country: Turkey
facility: Research Site
city: Kütahya
country: Turkey
facility: Research Site
city: Malatya
country: Turkey
facility: Research Site
city: Samsun
country: Turkey
facility: Research Site
city: Sivas
country: Turkey
facility: Research Site
city: Chernivtsі
country: Ukraine
facility: Research Site
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Ternopil
country: Ukraine
facility: Research Site
city: Ternopil
country: Ukraine
facility: Research Site
city: Uzhhorod
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Zhytomyr
country: Ukraine
facility: Research Site
city: Aberdeen
country: United Kingdom
facility: Research Site
city: Chesterfield
country: United Kingdom
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: Gatley
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Norwich
country: United Kingdom
facility: Research Site
city: Penzance
country: United Kingdom
facility: Research Site
city: Redruth
country: United Kingdom
facility: Research Site
city: Sandbach
country: United Kingdom
facility: Research Site
city: Southampton
country: United Kingdom
facility: Research Site
city: Stockton-on-Tees
country: United Kingdom
facility: Research Site
city: Swansea
country: United Kingdom
facility: Research Site
city: Weston-Super-Mare
country: United Kingdom
facility: Research Site
city: Wolverhampton
country: United Kingdom
facility: Research Site
city: Woodbridge
country: United Kingdom
facility: Research Site
city: Yate
country: United Kingdom
facility: Research Site
city: Ha Noi
country: Vietnam
facility: Research Site
city: Hai Phong
country: Vietnam
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Hcmc
country: Vietnam
facility: Research Site
city: Ho Chi Minh City
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Hue
country: Vietnam
facility: Research Site
city: Vinh Yen
country: Vietnam
facility: Research Site
Study officials:
References: