[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiac-remodeling\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiac-remodeling":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100649486","phase-4-hormone-therapy-effects-on-brain-heart-health-during-the-menopausal-transition-100649486",false,"NCT07732452","Hormone thERapy Effects on BRAin-HEART Health During the Menopausal Transition","HER BRAVE HEART Trial - Hormone thERapy Effects on BRAin-HEART Health During the Menopausal Transition: A Randomized Feasibility Study","HERBRAVEHEART","Inclusion Criteria:\n\n* Women aged ≥ 45 years.\n* Perimenopausal or postmenopausal, defined as at least one of the following:\n\n  * Perimenopause, defined as menstrual cycle irregularity (changes in cycle length, skipped cycles, or amenorrhea ≥ 60 days) accompanied by vasomotor symptoms consistent with the menopausal transition.\n  * Postmenopause, defined as at least one of:\n\n    * ≥ 12 months of spontaneous amenorrhea, or\n    * bilateral oophorectomy, or\n    * hysterectomy with FSH \\> 40 IU\u002FL when menstrual history is unavailable.\n* Vasomotor symptoms with a negative impact on quality of life, defined as :\n\n  * Recurrent hot flashes (sudden sensations of heat, typically involving the face, neck, or chest, often associated with flushing and\u002For sweating), and\u002For\n  * Night sweats (episodes of excessive sweating during sleep), With associated interference in daily functioning, sleep, or overall quality of life, such that the participant would be an appropriate candidate for systemic menopausal hormone therapy in clinical practice.\n* Presence of at least one cardiovascular risk factor, defined as either:\n\n  * Hypertension (diagnosed hypertension, use of antihypertensive medication, or blood pressure ≥ 140\u002F90 mmHg on screening).\n  * Dyslipidemia (diagnosed dyslipidemia, use of lipid-lowering therapy, LDL ≥ 3.0 mmol\u002FL, or total cholesterol ≥ 5.2 mmol\u002FL).\n  * Type 2 diabetes mellitus, defined as HbA1c ≥ 6.5%, fasting plasma glucose ≥ 7.0 mmol\u002FL, or use of glucose-lowering medication.\n  * Obesity (body mass index ≥ 30 kg\u002Fm²).\n  * Current smoking.\n  * First-degree family history of premature cardiovascular disease, defined as myocardial infarction, stroke, or documented coronary artery disease occurring before age 55 years in a male relative or before age 65 years in a female relative.\n* Eligible for systemic MHT (i.e., no formal contraindication to MHT).\n* Able and willing to undergo research CMR and attend the 12-month follow-up assessment.\n* Able to provide written informed consent.\n* Not currently using systemic MHT at baseline, or willing to discontinue systemic MHT prior to randomization and remain off systemic MHT until allocation and baseline assessments are complete.\n\nExclusion Criteria:\n\n* Prior cardiovascular event or established cardiovascular disease, including myocardial infarction, stroke or TIA, coronary artery disease, heart failure, cardiomyopathy, or clinically significant valvular heart disease.\n* Uncontrolled hypertension or other unstable cardiovascular condition (e.g., unstable angina, decompensated heart failure, uncontrolled arrhythmia).\n* Formal contraindication to systemic menopausal hormone therapy, including estrogen-dependent cancer, unexplained vaginal bleeding, active severe liver disease, severe thrombophilia, antiphospholipid syndrome, prior or active VTE.\n* Standard contraindications to MRI (e.g., MRI-incompatible pacemakers or intracardiac devices, certain metallic implants, metallic foreign bodies in the eye, or severe claustrophobia not manageable).\n* Pregnant.\n* Active cancer on ongoing cardiotoxic chemotherapy.\n* Current use of systemic hormonal therapy outside the study strategy, including systemic menopausal hormone therapy, combined hormonal contraception, or systemic progestin-only contraception, with unwillingness or inability to discontinue prior to baseline and randomization.\n* Ten years or more since menopause, defined as ≥10 years from the final menstrual period or from bilateral oophorectomy\n* Participants currently using combined hormonal contraception or systemic progestin-only contraception who are willing to discontinue must complete a washout period of at least 4 weeks prior to the baseline visit and randomization","FEMALE","45 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The goal of this clinical trial is to learn whether it is feasible to conduct a larger study comparing transdermal menopausal hormone therapy (MHT) versus no hormone therapy in menopausal women with vasomotor symptoms (hot flashes and night sweats) and at least one cardiovascular risk factor. The main questions it aims to answer are:\n\n* What proportion of eligible women agree to be randomly assigned to either receive MHT or not?\n* How many participants complete the 12-month follow-up, including repeat heart imaging?\n* Does transdermal MHT affect early changes in heart muscle tissue as measured by cardiac MRI?\n\nResearchers will compare immediate initiation of transdermal estradiol (a skin gel or patch) to a no-hormone therapy strategy to see if MHT influences early cardiovascular and brain-vascular changes over 12 months.\n\nParticipants will:\n\n* Be randomly assigned to start transdermal MHT within 2 weeks, or to use no hormone therapy for at least the first 3 months\n* Undergo a cardiac MRI and retinal eye imaging at the start of the study and again at 12 months\n* Complete cognitive testing and questionnaires about symptoms, sleep, and stress at both visits\n* Provide a blood sample for storage and future analysis of heart and brain health markers\n* Receive follow-up phone calls at 3, 6, and 9 months to review symptoms, medications, and any health changes",[27,28,29,30,31,32,33,34,35],"Menopause","Perimenopause","Vasomotor Symptoms","Cardiovascular Disease Risk Factor","Menopausal Hormone Therapy","Cardiac Remodeling","Myocardial Fibrosis","Microvascular Dysfunction","Cognitive Function Assessment","NOT_YET_RECRUITING","2026-07-23",{"date":39,"type":40},"2026-07-29","ACTUAL",{"date":42,"type":21},"2026-11",{"date":44,"type":21},"2029-01",{"name":46,"class":47},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":56,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100641637","phase-3-baxdrostat-and-ventricular-remodeling-100641637","NCT07655362","Baxdrostat and Ventricular Remodeling","A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Baxdrostat on Ventricular Remodeling","BaxREMODEL","INCLUSION CRITERIA\n\n1. Individuals ≥18 years of age who are willing and able to provide signed informed consent\n2. History of hypertension (Systolic BP \\>140 and \\\u003C170 mmHg)\n3. Serum K+ ≥3.5 and \\\u003C5.0 mmol\u002FL at Screening\n4. Evidence of left ventricular (LV) hypertrophy ≤12 months prior to or at screening showing at least one (≥1) of the following:\n\n   * Interventricular septal (IVS) thickness by echocardiography: Female ≥1.2 cm or Male ≥1.3 cm\n   * Posterior wall (PW) thickness by echocardiography: Female ≥1.2 cm or Male ≥1.3 cm\n   * Left ventricular mass indexed to baseline body surface area (LVMi) by echocardiography: Female \\>95 g⁄m\\^2 or Male \\>115 g⁄m\\^2\n   * LVMi by cMRI: Female \\>68 g⁄m\\^2 or Male \\>85 g⁄m\\^2\n5. The presence of ≥1 of the following risk factors:\n\n   * Documented type 2 diabetes mellitus or a glycated hemoglobin (A1C) level ≥6.5%\n   * Estimated glomerular filtration rate (eGFR) 45-60 mL\u002Fmin\u002F1.73m\\^2 at Screening\n   * Urine albumin-creatinine ratio (UACR) ≥3 mg\u002Fmmol\n   * IVS ≥1.4 cm\n   * PW ≥1.4 cm\n   * LVMi ≥105 g⁄m\\^2 for female and ≥125 g⁄m\\^2 for male individuals (by echocardiography)\n   * History of HFpEF (LV ejection fraction ≥50%)\n   * NT-proBNP ≥125 pg\u002FmL (within past 6 months)\n6. Female individuals who are of childbearing age can only be considered eligible if:\n\n   * 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\n   * 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\n\nEXCLUSION\n\n1. 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\n2. Female individuals who are pregnant, or can get pregnant, are breast-feeding or are planning to breastfeed and are\u002Fwill 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\n3. Upper arm circumference \\\u003C18 cm or \\>43 cm at Screening\n4. Body mass index \\>40 kg\u002Fm\\^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.\n5. Contraindication or inability to undergo CMR scan\n6. Serum Na+ level \\\u003C135 mmol\u002FL at Screening\n7. A1C \\>10% if living with T2DM during the 30 days before Randomization\n8. At Screening\n\n   * Systolic BP ≤120 mmHg\n   * Heart rate \\>110 or \\\u003C45 bpm per electrocardiogram (ECG) performed at Screening\n   * eGFR \\\u003C45 mL\u002Fmin\u002F1.73m\\^2 at Screening\n   * New York Heart Association (NYHA) functional HF class IV\n9. At Screening or first IP intake\n\n   * White blood cell (WBC) count \\>15 X 10\\^9\u002FL or absolute neutrophil count \\\u003C1 X 10\\^9\u002FL\n   * Hemoglobin (Hb) \\\u003C100 g\u002FL and\u002For anticipated initiation of erythropoietin-stimulating agents and\u002For planned transfusion within 60 days after screening\n   * Serum aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) \\>3X upper limits of normal (ULN) with a corresponding bilirubin \\>34 μmol\u002FL unless the potential participant has a history of Gilbert syndrome\n10. Medical history\n\n    * Planned dialysis or kidney transplant during this research study\n    * Adrenal insufficiency\n    * Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including chronic obstructive pulmonary disease\n    * Secondary causes of hypertension eg. Cushing's syndrome, aortic coarctation, renal artery stenosis, uncontrolled hyperthyroidism, untreated hyperthyroidism, hypothyroidism or pheochromocytoma\n    * 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\n    * Acute coronary syndrome, myocardial infarction, stroke, unstable angina pectoris, hypertensive encephalopathy, transient ischemic attack, or hospitalization for HF, during the 30 days before Screening\n    * Persistent atrial fibrillation, left bundle branch block or any cardiac arrhythmia requiring treatment\n    * Severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history\n    * Clinical evidence of, or suspicion of, active infection (at the discretion of the Site Investigator)\n11. Surgical history\n\n    * Undergone a major cardiovascular surgical procedure (eg. percutaneous coronary intervention\u002Fcoronary artery bypass grafting or percutaneous coronary\n    * Intervention\u002Fcoronary artery bypass grafting) or major endoscopic procedure (thoracoscopic or laparoscopic) during the 60 days before Randomization\n    * Previous or planned coronary, carotid, or peripheral artery revascularization during the 45 days before Screening\n    * Prior solid organ transplant and\u002For cell transplants\n    * Previous cardiac device implant (eg. implantable cardioverter defibrillator\u002Fcardiac resynchronization therapy\u002Fpacemaker) or planned device implant ≤90 days after screening\n12. 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)\n13. 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\n14. Unwilling to discontinue taking K+ supplements\n15. On K+ binders within 30 days prior to Screening\n16. On or expected to initiate a strong cytochrome P450 3A (CYP3A) inducer (eg. carbamazepine, enzalutamide, mitotane, phenytoin, rifabutin, rifampin and St. John's wort)\n17. Prior treatment within 6 months prior to Screening with a cytotoxic therapy (eg. cisplatin, doxorubicin, etoposide, misoprostol, trastuzumab)\n18. Known hypersensitivity to baxdrostat or drugs of the same class or any of its excipients\n19. 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","ALL","18 Years",{"count":59,"type":21},286,[61],"PHASE3","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.\n\nTo determine if baxdrostat improves heart structure and function, the participants will:\n\n* take a baxdrostat or a placebo (a look-alike tablet that contains no drug) tablet once a day for 12 months\n* 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\n* 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",[32],[65,66,67,68,69,70],"Baxdrostat","Left Ventricle Remodeling","Double-blind","Randomized","Multicentre","Cardiorenal","2026-06-12",{"date":73,"type":40},"2026-06-17",{"date":75,"type":21},"2026-06-30",{"date":77,"type":21},"2028-12-31",{"name":79,"class":47},"Subodh Verma",2,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":56,"minAge":57,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":106},"100628060","cardiac-morphology-and-function-in-individuals-with-autonomic-dysreflexia-100628060","NCT07456722","Cardiac Morphology and Function in Individuals With Autonomic Dysreflexia","Assessment of Cardiac Morphology and Function in Individuals With and Without Autonomic Dysreflexia Due to Spinal Cord Injury or Disease","HEART_REMOD_AD","Inclusion Criteria:\n\n* adults aged 18 years or older\n* long-term (\\>10 years), motor-complete SCI\u002FD (AIS A and B)\n* Group A (24 individuals): high-level (\\>Th6) SCI\u002FD and autonomic dysreflexia\n* Group B (24 individuals): low-level (\\\u003CTh10) SCI\u002FD without autonomic dysreflexia\n* signed informed consent\n\nExclusion Criteria:\n\n* congenital heart defects\n* valvular disease(s)\n* cardiomyopathy\n* medium to severe arrhythmia\n* myocardial infarction\n* comorbidities causing morphologic heart changes including primary hypertension, aortic stenosis\n* comorbidities causing arterial hypertension\n* use of anti-hypertensive treatment\n* smokers\n* individuals after sacral deafferentation surgery\n* pregnancy\n* active implanted medical devices\n* claustrophobia\n* inability to comply with the measurement procedures",{"count":90,"type":21},48,"OBSERVATIONAL","This case-control study aims to investigate left ventricular remodeling in individuals with chronic spinal cord injury or disease (SCI\u002FD) (≥10 years) and autonomic dysreflexia (AD) who have no prior cardiovascular history. The primary objective is to compare cardiac changes between 24 individuals with high-level SCI\u002FD (above Th6) who have AD and 24 individuals with low-level SCI\u002FD (below Th10) who do not have AD. A secondary objective examines how factors such as age, sex, injury duration, and physical activity are associated with cardiac remodeling.\n\nAll 48 participants will undergo cardiac MRI as well as blood measurement of B-type natriuretic peptid to assess cardiac morphology and function. The findings could shed light on a potentially underestimated cardiovascular risk factor in the SCI\u002FD population.",[94,95,32],"Autonomic Dysreflexia","Spinal Cord Injuries and Disorders (SCI\u002FD)","2026-03-09",{"date":98,"type":40},"2026-03-11",{"date":100,"type":21},"2026-05-01",{"date":102,"type":21},"2028-10-31",{"name":104,"class":105},"Swiss Paraplegic Research, Nottwil","NETWORK",1]