Cardiac RemodelingPhase 3BaxREMODELNCT07655362
Baxdrostat and Ventricular Remodeling
A Phase 3 study testing Baxdrostat in people with Cardiac Remodeling, run by Subodh Verma at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Remodeling
- What is being tested?
- Baxdrostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 286 participants
- Where
- 2 sitesCanada
- Study dates
- 30 Jun 2026to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
- Contraindication or inability to undergo CMR scan
- Serum Na+ level <135 mmol/L at Screening
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- 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
- Medical history
- Planned dialysis or kidney transplant during this research study
- Adrenal insufficiency
- Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including chronic obstructive pulmonary disease
- Secondary causes of hypertension eg. Cushing's syndrome, aortic coarctation, renal artery stenosis, uncontrolled hyperthyroidism, untreated hyperthyroidism, hypothyroidism or pheochromocytoma
- HF due to infiltrative cardiomyopathy (eg. sarcoid, amyloid), arrhythmogenic right ventricular (RV) cardiomyopathy, Takutsubo cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, uncorrected more than moderate primary valve disease
- Acute coronary syndrome, myocardial infarction, stroke, unstable angina pectoris, hypertensive encephalopathy, transient ischemic attack, or hospitalization for HF, during the 30 days before Screening
- Persistent atrial fibrillation, left bundle branch block or any cardiac arrhythmia requiring treatment
- Severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history
- Clinical evidence of, or suspicion of, active infection (at the discretion of the Site Investigator)
- Surgical history
- Undergone a major cardiovascular surgical procedure (eg. percutaneous coronary intervention/coronary artery bypass grafting or percutaneous coronary
- Intervention/coronary artery bypass grafting) or major endoscopic procedure (thoracoscopic or laparoscopic) during the 60 days before Randomization
- Previous or planned coronary, carotid, or peripheral artery revascularization during the 45 days before Screening
- Prior solid organ transplant and/or cell transplants
- Previous cardiac device implant (eg. implantable cardioverter defibrillator/cardiac resynchronization therapy/pacemaker) or planned device implant ≤90 days after screening
- Prior treatment (within 30 days before Screening) with or currently on an angiotensin-receptor blocker (ARB) in combination with an angiotensin converting enzyme inhibitor (ACEi)
- Prior treatment (within 30 days before Screening) with or currently on a mineralocorticoid receptor antagonist (MRA) or a K+-sparing diuretic, or anticipated initiation of either of these agents during the study period
- Unwilling to discontinue taking K+ supplements
- On K+ binders within 30 days prior to Screening
- On or expected to initiate a strong cytochrome P450 3A (CYP3A) inducer (eg. carbamazepine, enzalutamide, mitotane, phenytoin, rifabutin, rifampin and St. John's wort)
- Prior treatment within 6 months prior to Screening with a cytotoxic therapy (eg. cisplatin, doxorubicin, etoposide, misoprostol, trastuzumab)
- Known hypersensitivity to baxdrostat or drugs of the same class or any of its excipients
- Participation in another clinical study involving the investigational drug within 30 days prior to Screening or has plans to participate in another clinical study within 30 days of discontinuing the investigational drug
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
North York Diagnostic and Cardiac Centre
North York, Ontario, M6B3H7
Subodh Verma, MD, PhD, 416-783-0000, subodh.verma@nydcc.ca
Diagnostic Assessment Centre
Toronto, Ontario, M1S4N6
Subodh Verma, MD, PhD, 416-291-7300, subodh.verma@nydcc.ca
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Baxdrostat on Ventricular Remodeling
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
Read the detailed description
The BaxREMODEL CardioLink-18 Research Study is a multicentre, prospective, randomized, double-blind, parallel research study of baxdrostat vs placebo in addition to standard-of-care in adults with a history of hypertension and either cardiovascular or cardiorenal risk factors plus evidence of left ventricular hypertrophy or increased left ventricular mass. A total of 286 individuals will be assigned (1:1) to receive either baxdrostat 2 mg or placebo QD for 12 months.
- Conditions
- Cardiac Remodeling
- Being tested
- Baxdrostat, Placebo
- Keywords
- Baxdrostat, Left Ventricle Remodeling, Double-blind, Randomized, Multicentre, Cardiorenal
- Medical subject headings
- Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaxdrostatDrug
Participants will take 2mg baxdrostat (Baxfendy) once daily (orally), in addition to standard-of-care.
PlaceboDrug
Participants will take placebo once daily (orally), in addition to standard-of-care.
| Study group | Role | What they receive |
|---|---|---|
| Baxdrostat | Active comparator | Active treatment group Receives: Drug: Baxdrostat |
| Placebo | Placebo comparator | Control treatment group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (7)
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.
Measured: 12 months
Left Ventricular Ejection Fraction (LVEF)
Change in LVEF, measured by cMRI, from baseline to 12 months of treatment with baxdrostat compared to placebo.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Right Ventricular Ejection Fraction (RVEF)
Change in RVEF, measured by cMRI, from baseline to 12 months of treatment with baxdrostat compared to placebo.
Measured: 12 months
Right Ventricular End-Diastolic Volume indexed to baseline body surface area (RVEDVi)
Change in RVEDVi, measured by cMRI and indexed to baseline body surface area, from baseline to 12 months of treatment with baxdrostat compared to placebo.
Measured: 12 months
Right Ventricular End-Systolic Volume indexed to baseline body surface area (RVESVi)
Change in RVESVi, measured by cMRI and indexed to baseline body surface area, from baseline to 12 months of treatment with baxdrostat compared to placebo.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RemodelingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, double-blinded, randomized (1:1), placebo-controlled trial of baxdrostat vs placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Subodh Verma
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Subodh Verma, Canadian Medical and Surgical Knowledge Translation Research Group
- Investigators
- Subodh Verma, MD, PhD, Principal investigator, North York Diagnostic and Cardiac Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655362
- Sponsor's protocol ID
- CL-0018
- Acronym
- BaxREMODEL
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Baxdrostat on Ventricular Remodeling
- ClinicalTrials.gov ID
- NCT07655362
- Acronym / sponsor ID
- BaxREMODEL / CL-0018
- Conditions
- Cardiac Remodeling
- Keywords
- Baxdrostat, Left Ventricle Remodeling, Double-blind, Randomized, Multicentre, Cardiorenal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Subodh VermaUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The BaxREMODEL CardioLink-18 Research Study is a multicentre, prospective, randomized, double-blind, parallel research study of baxdrostat vs placebo in addition to standard-of-care in adults with a history of hypertension and either cardiovascular or cardiorenal risk factors plus evidence of left ventricular hypertrophy or increased left ventricular mass. A total of 286 individuals will be assigned (1:1) to receive either baxdrostat 2 mg or placebo QD for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, double-blinded, randomized (1:1), placebo-controlled trial of baxdrostat vs placebo
| Arm | Type | Receives |
|---|---|---|
| Baxdrostat | Active comparator | Drug: BaxdrostatActive treatment group |
| Placebo | Placebo comparator | Drug: PlaceboControl treatment group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
- The presence of ≥1 of the following risk factors:
Key exclusion criteria (40 listed)
- 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.
- Contraindication or inability to undergo CMR scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaxdrostatParticipants will take 2mg baxdrostat (Baxfendy) once daily (orally), in addition to standard-of-care. | Drug | Baxdrostat |
| PlaceboParticipants will take placebo once daily (orally), in addition to standard-of-care. | Drug | Placebo |
Primary outcome
Left Ventricular Mass indexed to baseline body surface area (LVMi)
Time frame: 12 months
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.
7 secondary outcomes
Left Atrial Volume indexed to baseline body surface area (LAVi)
Time frame: 12 months
Left Ventricular Ejection Fraction (LVEF)
Time frame: 12 months
Left Ventricular End-Diastolic Volume indexed to baseline body surface area (LVEDVi)
Time frame: 12 months
Left Ventricular End-Systolic Volume indexed to baseline body surface area (LVESVi)
Time frame: 12 months
Right Ventricular Ejection Fraction (RVEF)
Time frame: 12 months
Right Ventricular End-Diastolic Volume indexed to baseline body surface area (RVEDVi)
Time frame: 12 months
Right Ventricular End-Systolic Volume indexed to baseline body surface area (RVESVi)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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RecruitingPhase 4
Vericiguat and Reverse Remodeling Indices in Heart Failure
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Subodh Verma, MD, PhD principal investigator
North York Diagnostic and Cardiac Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Baxdrostat in people with Cardiac Remodeling, run by Subodh Verma at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Subodh Verma, MD, PhD (416-864-5997, subodh.verma@nydcc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Mass indexed to baseline body surface area (LVMi) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.