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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06677060




Registration number
NCT06677060
Ethics application status
Date submitted
5/11/2024
Date registered
6/11/2024

Titles & IDs
Public title
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
Scientific 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
Secondary ID [1] 0 0
D6973C00001
Universal Trial Number (UTN)
Trial acronym
Prevent-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Baxdrostat and dapagliflozin
Other interventions - Placebo and dapagliflozin

Experimental: Baxdrostat/Dapagliflozin - Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a dose of baxdrostat lower dose and dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose.

Experimental: Placebo/Dapagliflozin - Patients will receive a dose of dapagliflozin in combination with matching placebo


Treatment: Drugs: Baxdrostat and dapagliflozin
baxdrostat tablet and dapagliflozin tablet

Other interventions: Placebo and dapagliflozin
placebo tablet and dapagliflozin tablet
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine if baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of an HF event or CV death
Timepoint [1] 0 0
Event driven; Up to 38 months
Secondary outcome [1] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of hospitalisation for HF or CV death
Timepoint [1] 0 0
Event driven; Up to 38 months
Secondary outcome [2] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of HF events
Timepoint [2] 0 0
Event driven; Up to 38 months
Secondary outcome [3] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of CV death
Timepoint [3] 0 0
Event driven; Up to 38 months
Secondary outcome [4] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of all-cause mortality
Timepoint [4] 0 0
Event driven; Up to 38 months
Secondary outcome [5] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of stroke or CV death
Timepoint [5] 0 0
Event driven; Up to 38 months
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Event driven; Up to 38 months
Secondary outcome [7] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of MI or CV death
Timepoint [7] 0 0
Event driven; Up to 38 months

Eligibility
Key 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 = 3.0 to = 4.8 mmol/L at screening
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
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Established heart failure diagnosis
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
28/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/12/2029
Actual
Sample size
Target
11300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Geelong
Recruitment hospital [2] 0 0
Research Site - Maroubra
Recruitment hospital [3] 0 0
Research Site - Wollongong
Recruitment postcode(s) [1] 0 0
3220 - Geelong
Recruitment postcode(s) [2] 0 0
2035 - Maroubra
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Caba
Country [2] 0 0
Argentina
State/province [2] 0 0
Mar del Plata
Country [3] 0 0
Bulgaria
State/province [3] 0 0
Haskovo
Country [4] 0 0
Bulgaria
State/province [4] 0 0
Pleven
Country [5] 0 0
Bulgaria
State/province [5] 0 0
Sofia
Country [6] 0 0
Canada
State/province [6] 0 0
Alberta
Country [7] 0 0
Canada
State/province [7] 0 0
Nova Scotia
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Germany
State/province [9] 0 0
Aachen
Country [10] 0 0
Germany
State/province [10] 0 0
Bad Oeynhausen
Country [11] 0 0
Germany
State/province [11] 0 0
Bamberg
Country [12] 0 0
Germany
State/province [12] 0 0
Bechhofen
Country [13] 0 0
Germany
State/province [13] 0 0
Berlin
Country [14] 0 0
Germany
State/province [14] 0 0
Bochum
Country [15] 0 0
Germany
State/province [15] 0 0
Deggingen
Country [16] 0 0
Germany
State/province [16] 0 0
Dresden
Country [17] 0 0
Germany
State/province [17] 0 0
Essen
Country [18] 0 0
Germany
State/province [18] 0 0
Freiburg
Country [19] 0 0
Germany
State/province [19] 0 0
Fulda
Country [20] 0 0
Germany
State/province [20] 0 0
Gelnhausen
Country [21] 0 0
Germany
State/province [21] 0 0
Görlitz
Country [22] 0 0
Germany
State/province [22] 0 0
Hamburg
Country [23] 0 0
Germany
State/province [23] 0 0
Haßloch
Country [24] 0 0
Germany
State/province [24] 0 0
Heidelberg
Country [25] 0 0
Germany
State/province [25] 0 0
Homburg
Country [26] 0 0
Germany
State/province [26] 0 0
Kaiserslautern
Country [27] 0 0
Germany
State/province [27] 0 0
Kassel
Country [28] 0 0
Germany
State/province [28] 0 0
Köln
Country [29] 0 0
Germany
State/province [29] 0 0
Langen
Country [30] 0 0
Germany
State/province [30] 0 0
Leipzig
Country [31] 0 0
Germany
State/province [31] 0 0
Ludwigshafen
Country [32] 0 0
Germany
State/province [32] 0 0
Markkleeberg
Country [33] 0 0
Germany
State/province [33] 0 0
Münster
Country [34] 0 0
Germany
State/province [34] 0 0
Naunhof
Country [35] 0 0
Germany
State/province [35] 0 0
Neuruppin
Country [36] 0 0
Germany
State/province [36] 0 0
Nittendorf
Country [37] 0 0
Germany
State/province [37] 0 0
Papenburg
Country [38] 0 0
Germany
State/province [38] 0 0
Völklingen
Country [39] 0 0
Germany
State/province [39] 0 0
Wangen
Country [40] 0 0
Greece
State/province [40] 0 0
Athens
Country [41] 0 0
Greece
State/province [41] 0 0
Chania
Country [42] 0 0
Greece
State/province [42] 0 0
Ioannina
Country [43] 0 0
Greece
State/province [43] 0 0
Larissa
Country [44] 0 0
Greece
State/province [44] 0 0
Piraeus
Country [45] 0 0
Greece
State/province [45] 0 0
Thessaloniki
Country [46] 0 0
Italy
State/province [46] 0 0
Bergamo
Country [47] 0 0
Malaysia
State/province [47] 0 0
Alor Setar
Country [48] 0 0
Malaysia
State/province [48] 0 0
Kota Samarahan
Country [49] 0 0
Malaysia
State/province [49] 0 0
Kuantan
Country [50] 0 0
Malaysia
State/province [50] 0 0
Sarawak Miri
Country [51] 0 0
Malaysia
State/province [51] 0 0
Sungai Buloh
Country [52] 0 0
Netherlands
State/province [52] 0 0
Amsterdam
Country [53] 0 0
Netherlands
State/province [53] 0 0
Deventer
Country [54] 0 0
Netherlands
State/province [54] 0 0
Groningen
Country [55] 0 0
Netherlands
State/province [55] 0 0
Hoogeveen
Country [56] 0 0
Netherlands
State/province [56] 0 0
Rotterdam
Country [57] 0 0
Philippines
State/province [57] 0 0
Cebu
Country [58] 0 0
Philippines
State/province [58] 0 0
Davao City
Country [59] 0 0
Philippines
State/province [59] 0 0
Fuente Osmena Cebu City
Country [60] 0 0
Philippines
State/province [60] 0 0
Puerto Princesa City
Country [61] 0 0
Philippines
State/province [61] 0 0
Roxas City
Country [62] 0 0
South Africa
State/province [62] 0 0
Centurion
Country [63] 0 0
South Africa
State/province [63] 0 0
Worcester
Country [64] 0 0
Thailand
State/province [64] 0 0
Bangkok
Country [65] 0 0
Thailand
State/province [65] 0 0
Banphaeo
Country [66] 0 0
Thailand
State/province [66] 0 0
Bansuan, Muang, Chonburi
Country [67] 0 0
Thailand
State/province [67] 0 0
Chiang Mai
Country [68] 0 0
Thailand
State/province [68] 0 0
Dusit
Country [69] 0 0
Thailand
State/province [69] 0 0
Hat Yai
Country [70] 0 0
Thailand
State/province [70] 0 0
Khlong Luang
Country [71] 0 0
Thailand
State/province [71] 0 0
Khon Kaen
Country [72] 0 0
Thailand
State/province [72] 0 0
Muang
Country [73] 0 0
Thailand
State/province [73] 0 0
Naimuang
Country [74] 0 0
Thailand
State/province [74] 0 0
Ubonratchathani

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available to whom?
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06677060