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

RecruitingPhase 3Ages 40 Years - anyAllAstraZeneca
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In plain words

What the trial is, and whether it could suit you

Participants include men and women โ‰ฅ 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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Participants of any sex and gender must be โ‰ฅ 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 โ‰ฅ 130 mmHg at screening and โ‰ฅ 120 mmHg at the Randomisation Visit. * At least one additional risk factor for HF: * Age โ‰ฅ 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 โ‰ฅ 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
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What it tests

  • Baxdrostat and dapagliflozin
  • Placebo and dapagliflozin
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Where

977 sites
Research Site
Birmingham, United States
Research Site
Centreville, United States
Research Site
Fairhope, United States
Research Site
Huntsville, United States
Research Site
Mobile, United States
Research Site
Sheffield, United States
Research Site
Vestavia Hills, United States
Research Site
Anchorage, United States

โ€ฆand 969 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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