Baxdrostat and Ventricular Remodeling

NCT07655362 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CL-0018
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cardiac Remodeling

Keywords

Baxdrostat; Left Ventricle Remodeling; Double-blind; Randomized; Multicentre; Cardiorenal

Outcome Measures

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.

  12 months

Secondary Outcomes (7)

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

  12 months

• Left Ventricular Ejection Fraction (LVEF)

  12 months

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

  12 months

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

  12 months

• Right Ventricular Ejection Fraction (RVEF)

  12 months

Study Arms (2)

Baxdrostat

ACTIVE COMPARATOR

Active treatment group

Drug: Baxdrostat

Placebo

PLACEBO COMPARATOR

Control treatment group

Drug: Placebo

Interventions

Baxdrostat DRUG

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

Baxdrostat

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

You may not qualify if:

• 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
• 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.
• Contraindication or inability to undergo CMR scan
• Serum Na+ level \<135 mmol/L at Screening
• A1C \>10% if living with T2DM during the 30 days before Randomization
• At Screening
• Systolic BP ≤120 mmHg
• Heart rate \>110 or \<45 bpm per electrocardiogram (ECG) performed at Screening
• eGFR \<45 mL/min/1.73m\^2 at Screening
• New York Heart Association (NYHA) functional HF class IV
• At Screening or first IP intake
• White blood cell (WBC) count \>15 X 10\^9/L or absolute neutrophil count \<1 X 10\^9/L
• Hemoglobin (Hb) \<100 g/L and/or anticipated initiation of erythropoietin-stimulating agents and/or planned transfusion within 60 days after screening
• Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>3X upper limits of normal (ULN) with a corresponding bilirubin \>34 μmol/L unless the potential participant has a history of Gilbert syndrome

Sponsors & Collaborators

• Subodh Verma: lead
• AstraZeneca: collaborator

Study Sites (2)

North York Diagnostic and Cardiac Centre

North York, Ontario, M6B3H7, Canada

Location

Diagnostic Assessment Centre

Toronto, Ontario, M1S4N6, Canada

Location

MeSH Terms

Conditions

Ventricular Remodeling

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Subodh Verma, MD, PhD

  North York Diagnostic and Cardiac Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Subodh Verma, MD, PhD

CONTACT

416-864-5997; subodh.verma@nydcc.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery and Pharmacology & Toxicology

Model Details: Prospective, double-blinded, randomized (1:1), placebo-controlled trial of baxdrostat vs placebo

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)