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New treatment option for Heart Failure
Official title Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
ClinicalTrials.gov ID: NCT06677060
What this study is testing
What is Baxdrostat and dapagliflozin?
Baxdrostat and dapagliflozin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for heart failure.
Also referred to as Baxdrostat CIN-107.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Participants of any sex and gender must be ≥ 40 years old at the time of signing the informed consent.
- Diagnosed with T2DM and requiring treatment
- Established CV disease (ischaemic heart disease, cerebrovascular disease, peripheral arterial disease)
- History of HTN and an SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the Randomisation Visit.
- At least one additional risk factor for HF:
You likely can't join if
- Previously confirmed diagnosis and treatment of heart failure
- An eGFR \< 30 mL/min/1.73 m2 at screening
- Known hyperkalaemia, defined as potassium ≥ 5.5 mmol/L within 3 months prior to screening
- Type 1 diabetes mellitus or uncontrolled T2DM with HbA1c \> 10.5% (\> 91 mmol/mol) at screening
- Serum sodium \< 135 mmol/L at screening, determined as per central laboratory assessment
- Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, carotid angioplasty, or cardiac surgery...
See the full eligibility criteria
- Participants of any sex and gender must be ≥ 40 years old at the time of signing the informed consent.
- Diagnosed with T2DM and requiring treatment
- Established CV disease (ischaemic heart disease, cerebrovascular disease, peripheral arterial disease)
- History of HTN and an SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the Randomisation Visit.
- 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
- Previously confirmed diagnosis and treatment of heart failure
- An eGFR \< 30 mL/min/1.73 m2 at screening
- Known hyperkalaemia, defined as potassium ≥ 5.5 mmol/L within 3 months prior to screening
- Type 1 diabetes mellitus or uncontrolled T2DM with HbA1c \> 10.5% (\> 91 mmol/mol) at screening
- Serum sodium \< 135 mmol/L at screening, determined as per central laboratory assessment
- Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, carotid angioplasty, or cardiac surgery, within 3 months prior to randomisation
- Myocardial infarction within 3 months prior to randomisation, or within 1 month prior to randomisation when there is no further planned revascularisation
- Percutaneous coronary intervention within 1 month prior to randomisation
- Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history
- Documented history of adrenal insufficiency
- Any dialysis (including for acute kidney injury) within 3 months prior to screening
- Any acute kidney injury within 3 months prior to screening
- Prohibited concomitant medications
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Centreville, Alabama, United States
- Fairhope, Alabama, United States
- Huntsville, Alabama, United States
- Mobile, Alabama, United States
- Sheffield, Alabama, United States
- Vestavia Hills, Alabama, United States
- Anchorage, Alaska, United States
- Gilbert, Arizona, United States
- Glendale, Arizona, United States
- Tempe, Arizona, United States
- Tucson, Arizona, United States
- Dublin, California, United States
- Huntington Beach, California, United States
- Inglewood, California, United States
- La Jolla, California, United States
- Lakewood, California, United States
- Lincoln, California, United States
- Loma Linda, California, United States
- Los Angeles, California, United States
+ 715 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Centreville, Alabama, United States; Fairhope, Alabama, United States; Huntsville, Alabama, United States; Mobile, Alabama, United States; Sheffield, Alabama, United States and 729 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.