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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
2024-514506-32-00
Secondary ID [2] 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 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
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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 - Fremantle
Recruitment hospital [2] 0 0
Research Site - Geelong
Recruitment hospital [3] 0 0
Research Site - Kingswood
Recruitment hospital [4] 0 0
Research Site - Maroubra
Recruitment hospital [5] 0 0
Research Site - Merewether
Recruitment hospital [6] 0 0
Research Site - Spearwood
Recruitment hospital [7] 0 0
Research Site - Wollongong
Recruitment postcode(s) [1] 0 0
6160 - Fremantle
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment postcode(s) [3] 0 0
2747 - Kingswood
Recruitment postcode(s) [4] 0 0
2035 - Maroubra
Recruitment postcode(s) [5] 0 0
2291 - Merewether
Recruitment postcode(s) [6] 0 0
6163 - Spearwood
Recruitment postcode(s) [7] 0 0
2500 - Wollongong
Recruitment outside Australia
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Argentina
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Buenos Aires
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Argentina
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Caba
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Rosario
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Santa Fe
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Blumenau
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Brasilia
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Woodbridge
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Hai Phong
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Vietnam
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Hue
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Vinh Yen

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
[email protected]
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