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Heart-Thickening drug trial aims to reverse damage

NCT ID NCT07655362

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This Phase 3 trial tests whether adding baxdrostat (Baxfendy) to standard care can improve heart structure and function in 286 adults with high blood pressure and thickened heart walls. Participants take either baxdrostat or a placebo daily for 12 months, with heart scans and regular checkups to measure changes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
baxdrostat (Baxfendy)
What this could lead to
If successful, baxdrostat could become a new add-on treatment to help reverse heart thickening and improve heart function in people with high blood pressure.
What could go wrong
This is a Phase 3 trial, but results are not yet known. The drug may not improve heart structure more than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 286 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

INCLUSION CRITERIA 1. Individuals ≥18 years of age who are willing and able to provide signed informed consent 2. History of hypertension (Systolic BP \>140 and \<170 mmHg) 3. Serum K+ ≥3.5 and \<5.0 mmol/L at Screening 4. 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 5. 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) 6. 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 1. 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 2. 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 3. Upper arm circumference \<18 cm or \>43 cm at Screening 4. 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. 5. Contraindication or inability to undergo CMR scan 6. Serum Na+ level \<135 mmol/L at Screening 7. A1C \>10% if living with T2DM during the 30 days before Randomization 8. 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 9. 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 10. 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) 11. 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 12. 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) 13. 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 14. Unwilling to discontinue taking K+ supplements 15. On K+ binders within 30 days prior to Screening 16. On or expected to initiate a strong cytochrome P450 3A (CYP3A) inducer (eg. carbamazepine, enzalutamide, mitotane, phenytoin, rifabutin, rifampin and St. John's wort) 17. Prior treatment within 6 months prior to Screening with a cytotoxic therapy (eg. cisplatin, doxorubicin, etoposide, misoprostol, trastuzumab) 18. Known hypersensitivity to baxdrostat or drugs of the same class or any of its excipients 19. 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

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Conditions

The condition(s) this trial relates to.

hypertensive disorder Ventricular Remodeling

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Diagnostic Assessment Centre

    Toronto, Ontario, M1S4N6, Canada

  • North York Diagnostic and Cardiac Centre

    North York, Ontario, M6B3H7, Canada

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