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RecruitingPhase 3

Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests baxdrostat with dapagliflozin to see how they affect heart failure and death from heart or blood vessel disease. It is for adults age 40 or older with type 2 diabetes, heart or blood vessel disease, high blood pressure, and another risk factor for heart failure.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 40 or older. People of any sex or gender may join.
  • Have type 2 diabetes that needs treatment.
  • Have disease in the blood vessels that supply the heart, brain, or limbs.
  • Have a history of high blood pressure. The top blood pressure number must be at least 130 at screening and at least 120 when assigned to a study group.
  • Have at least one added heart failure risk: age 70 or older; urine protein test (UACR) over 20 mg/g; kidney filter test (eGFR) below 60; blood vessel disease in at least two areas listed above; atrial fibrillation or flutter (types of irregular heartbeat); or NT-proBNP, a blood marker of heart strain, over 125 ng/L.
  • Meet the study's blood potassium requirements.

Who can't join

  • Have already been diagnosed with and treated for heart failure.
  • Have a kidney filter test (eGFR) below 30 at screening, or had sudden kidney injury or dialysis (blood-filtering treatment) in the past 3 months.
  • Had high blood potassium of at least 5.5 mmol/L in the 3 months before screening, or have blood sodium below 135 mmol/L at screening.
  • Have type 1 diabetes, or type 2 diabetes with an HbA1c over 10.5% at screening. HbA1c measures average blood sugar.
  • Had a stroke, mini-stroke, heart valve procedure, heart surgery, or surgery or balloon treatment on a neck artery in the 3 months before group assignment.
  • Had a heart attack in the 3 months before group assignment, or within 1 month if no further procedure to restore blood flow is planned. Also excluded: a catheter procedure to open heart arteries within 1 month.
  • Have severe liver disease (Child-Pugh Class C), or a history of adrenal glands not making enough hormones.
  • Take medicines that the study does not allow.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 Exclusion Criteria: * 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

Study sites (198)

AK

AL

AZ

CA

CO

CT

FL

GA

ID

IL

IN

KS

KY

LA

MA

MD

MI

MN

MO

MT

NC

ND

NE

NH

NJ

NM

NV

NY

OH

OK

OR

PA

SC

TN

TX

UT

VA

VT

WA

WI

WV