Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin (NCT06677060)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
Participants include men and women โฅ 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.
Who can join: Review the eligibility criteria below.
Location: Research Site โ Birmingham, Alabama
Age range: 40 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (953 Sites)
Showing the first 25 of 953 sites.
- Research Site โ Birmingham, Alabama
- Research Site โ Centreville, Alabama
- Research Site โ Fairhope, Alabama
- Research Site โ Huntsville, Alabama
- Research Site โ Mobile, Alabama
- Research Site โ Sheffield, Alabama
- Research Site โ Vestavia Hills, Alabama
- Research Site โ Anchorage, Alaska
- Research Site โ Gilbert, Arizona
- Research Site โ Glendale, Arizona
- Research Site โ Tempe, Arizona
- Research Site โ Tucson, Arizona
- Research Site โ Dublin, California
- Research Site โ Huntington Beach, California
- Research Site โ Inglewood, California
- Research Site โ La Jolla, California
- Research Site โ Lakewood, California
- Research Site โ Lincoln, California
- Research Site โ Loma Linda, California
- Research Site โ Los Angeles, California
- Research Site โ Los Angeles, California
- Research Site โ Sacramento, California
- Research Site โ San Diego, California
- Research Site โ San Dimas, California
- Research Site โ San Francisco, California
๐ Contact the Study Coordinator
Phone: (877) 240-9479
Email: information.center@astrazeneca.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.