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A Phase III, Randomised, Double-Blind, 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 in Participants with Increased Risk of Developing Heart Failure

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514506-32-00
Acronym
D6973C00001
Enrollment
3868
Registered
2025-04-14
Start date
2025-05-06
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of Heart failure

Brief summary

Time to first occurrence of any of the components of the composite of: • Hospitalisation for HF • HF without hospitalisation • CV death

Detailed description

Time to first occurrence of any of the components of the composite of: • Hospitalisation for HF • CV death, Time to first occurrence of any of the components of the composite of: • Hospitalisation for HF • HF without hospitalisation, Time to CV death, Time to all-cause death, Time to first occurrence of any of the components of the composite of: • Stroke • CV death, Time to first occurrence of any of the components of the composite of: • New diagnosis of atrial fibrillation • CV death, Time to first occurrence of any of the components of the composite of: • MI • CV death

Interventions

DRUGForxiga 10 mg film-coated tablets

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time to first occurrence of any of the components of the composite of: • Hospitalisation for HF • HF without hospitalisation • CV death

Secondary

MeasureTime frame
Time to first occurrence of any of the components of the composite of: • Hospitalisation for HF • CV death, Time to first occurrence of any of the components of the composite of: • Hospitalisation for HF • HF without hospitalisation, Time to CV death, Time to all-cause death, Time to first occurrence of any of the components of the composite of: • Stroke • CV death, Time to first occurrence of any of the components of the composite of: • New diagnosis of atrial fibrillation • CV death, Time to first occurrence of any of the components of the composite of: • MI • CV death

Countries

Bulgaria, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Romania, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026