Health TrialsbyHealthPanel

Baxdrostat and Ventricular Remodeling

ConditionCardiac 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Baxdrostat

    Drug

    Participants will take 2mg baxdrostat (Baxfendy) once daily (orally), in addition to standard-of-care.

  • Placebo

    Drug

    Participants will take placebo once daily (orally), in addition to standard-of-care.

Treatment groups

286 Participants
are divided into 2 treatment groups
Group A: BaxdrostatActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Left Ventricular Mass indexed to baseline body surface area (LVMi)

Change in LVMi (g/m\^2), measured by cardiac magnetic resonance imaging (cMRI) from baseline to 12 months of treatment with baxdrostat compared to placebo.

Time frame
12 months

Secondary outcomes

1

Left Atrial Volume indexed to baseline body surface area (LAVi)

Change in LAVi, measured by cMRI and indexed to baseline body surface area, from baseline to 12 months of treatment with baxdrostat compared to placebo.

Time frame
12 months
2

Left Ventricular Ejection Fraction (LVEF)

Change in LVEF, measured by cMRI, from baseline to 12 months of treatment with baxdrostat compared to placebo.

Time frame
12 months
3

Left Ventricular End-Diastolic Volume indexed to baseline body surface area (LVEDVi)

Change in LVEDVi, measured by cMRI and indexed to baseline body surface area, from baseline to 12 months of treatment with baxdrostat compared to placebo.

Time frame
12 months
4

Left Ventricular End-Systolic Volume indexed to baseline body surface area (LVESVi)

Change in LVESVi, measured by cMRI and indexed to baseline body surface area, from baseline to 12 months of treatment with baxdrostat compared to placebo.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Subodh Verma

Lead sponsor

Canadian Medical and Surgical Knowledge Translation Research Group

Sponsor institution

AstraZeneca

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: