Baxdrostat and Ventricular Remodeling

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Cardiac Remodeling

In brief

The goal of this trial is to learn whether adding the blood pressure medication baxdrostat (Baxfendy) to standard-of-care medical therapies will beneficially change the heart structure and function of adults who have high blood pressure, thickened left heart walls, and are at risk for heart or kidney disease. To determine if baxdrostat improves heart structure and function, the participants will: * take a baxdrostat or a placebo (a look-alike tablet that contains no drug) tablet once a day for 12 months * undergo a safe and non-invasive cardiac magnetic resonance imaging scan (to measure heart mass, stiffness and function) at the beginning of the study and 12 months later * visit the clinic for checkups and blood or urine tests 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months after taking the first tablet

Key facts

Study ID

NCT07655362

Run by

Subodh Verma

People needed

286

Starts

2026-06-30

Expected to finish

2028-12-31

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals ≥18 years of age who are willing and able to provide signed informed consent
• History of hypertension (Systolic BP >140 and <170 mmHg)
• Serum K+ ≥3.5 and <5.0 mmol/L at Screening
• Evidence of left ventricular (LV) hypertrophy ≤12 months prior to or at screening showing at least one (≥1) of the following:
• Interventricular septal (IVS) thickness by echocardiography: Female ≥1.2 cm or Male ≥1.3 cm
• Posterior wall (PW) thickness by echocardiography: Female ≥1.2 cm or Male ≥1.3 cm
• Left ventricular mass indexed to baseline body surface area (LVMi) by echocardiography: Female >95 g⁄m\^2 or Male >115 g⁄m\^2
• LVMi by cMRI: Female >68 g⁄m\^2 or Male >85 g⁄m\^2
• The presence of ≥1 of the following risk factors:
• Documented type 2 diabetes mellitus or a glycated hemoglobin (A1C) level ≥6.5%
• Estimated glomerular filtration rate (eGFR) 45-60 mL/min/1.73m\^2 at Screening
• Urine albumin-creatinine ratio (UACR) ≥3 mg/mmol
• IVS ≥1.4 cm
• PW ≥1.4 cm
• LVMi ≥105 g⁄m\^2 for female and ≥125 g⁄m\^2 for male individuals (by echocardiography)
• History of HFpEF (LV ejection fraction ≥50%)
• NT-proBNP ≥125 pg/mL (within past 6 months)
• Female individuals who are of childbearing age can only be considered eligible if:
• they are postmenopausal (amenorrhoeic for ≥12 months following cessation of exogenous hormonal treatment) or have had a surgical procedure (eg. hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) ≥6 months at Screening that prevents them from becoming pregnant or
• the result of their pregnancy test at the baseline visit is negative, and they agree to use at least one highly effective and one effective contraception method to avoid pregnancy during the 30 days before randomization, throughout the research study, and for at least 30 days after taking the last dose of the assigned IP
• EXCLUSION
• Considered unsuitable by the investigator for any reason that may either place the participant at increased risk during participation or interfere with the interpretation of the study outcomes
• Female individuals who are pregnant, or can get pregnant, are breast-feeding or are planning to breastfeed and are/will not be using at least one highly effective contraception method (see Inclusion Criteria section for definitions) during the 30 days before Randomization, throughout the research study, and for at least 30 days after taking the last dose of the assigned IP
• Upper arm circumference <18 cm or >43 cm at Screening
• Body mass index >40 kg/m\^2 (Image quality and accurate assessment of cardiac function degrades with obesity across all imaging modalities. Although CMR-derived images are the least compromised by high body mass indexes, MRI bore sizes and table weight limits, greater safety risks [eg. thermal burns] as well as increased frequencies of claustrophobia remain major challenges.

Where it is running

• North York Diagnostic and Cardiac Centre — North York, Ontario, Canada
• Diagnostic Assessment Centre — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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