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

Official 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 11,300 participants

Interventions

• DRUG: Baxdrostat and dapagliflozin — baxdrostat tablet and dapagliflozin tablet
• OTHER: Placebo and dapagliflozin — placebo tablet and dapagliflozin tablet

Primary Outcomes

• To determine if baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of an HF event or CV death (Event driven; Up to 38 months)

Secondary Outcomes

• To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of hospitalisation for HF or CV death (Event driven; Up to 38 months)
• To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of HF events (Event driven; Up to 38 months)
• To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of CV death (Event driven; Up to 38 months)
• To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of all-cause mortality (Event driven; Up to 38 months)
• To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of 4-point MACE (CV death, MI, stroke, and hospitalisation for HF) (Event driven; Up to 38 months)

Trial Locations

• Research Site, Birmingham, Alabama, United States
• Research Site, Centreville, Alabama, United States
• Research Site, Fairhope, Alabama, United States
• Research Site, Huntsville, Alabama, United States
• Research Site, Mobile, Alabama, United States
• Research Site, Vestavia Hills, Alabama, United States
• Research Site, Gilbert, Arizona, United States
• Research Site, Glendale, Arizona, United States
• Research Site, Tempe, Arizona, United States
• Research Site, Tucson, Arizona, United States
• ...and 10 more locations

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