Baxdrostat and Ventricular Remodeling

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSubodh Verma

About this trial

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

Eligibility criteria

Qualifiers

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

Interventricular septal (IVS) thickness by echocardiography: Female ≥1.2 cm or Male ≥1.3 cm

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Baxdrostat
  • Placebo

Treatment groups

286 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Subodh Verma

Lead sponsor

Canadian Medical and Surgical Knowledge Translation Research Group

Sponsor institution

AstraZeneca

Collaborator