[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiovascular-disease-cvd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiovascular-disease-cvd":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,86,119],{"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":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100611830","phase-3-commodities-trial-initial-dual-oral-therapy-vs-monotherapy-in-pah-with-cardiovascular-comorbidities-100611830",false,"NCT07245680","COMMODITIES Trial: Initial Dual Oral Therapy vs Monotherapy in PAH With Cardiovascular Comorbidities","Comparison of Initial Dual Oral COMbination Therapy to MOnotherapy in Pulmonary Arterial Hypertension With Cardiovascular comorbiDITIES","COMMODITIES","Inclusion Criteria:\n\n* Initial PAH diagnosis \\\u003C 6 months preceding randomisation\n\n  * Negative vasoreactivity test\n  * Treatment-naïve PAH (group 1): idiopathic, heritable, associated with drugs and toxin, associated with connective tissue disease, HIV infection or systemic-to-pulmonary congenital shunt corrected for more than one year\n  * Meet all of the following hemodynamic criteria by means of a RHC prior to screening:\n* mPAP≥25 mmHg and\n* PAWP\\\u003C15 mmHg and\n* with PVR≥3 WU\n\n  • Presence of at least two of the following criteria, as listed in the European pulmonary hypertension guidelines:\n* History of essential hypertension\n* Diabetes mellitus (any type)\n* Obesity (defined by a BMI ≥30 kg\u002Fm2)\n* Coronary heart disease (established by any of the following: history of myocardial infarction, history of percutaneous coronary intervention, angiographic evidence of coronary artery disease (\\>50% stenosis in ≥1 vessel), positive ST, previous coronary artery bypass graft, stable angina)\n\n  * Participant able to understand the study procedures\n  * For women of childbearing potential (WOCBP), effective form of contraception\\* from screening up to 1 month following discontinuation of the last study treatment\n  * Affiliation to the french social security regime\n  * Signed written informed consent\n\nExclusion Criteria:\n\n* Porto-pulmonary hypertension\n* Uncorrected systemic-to-pulmonary congenital shunt\n* Evidence of thromboembolic disease assessed by ventilation perfusion (V\u002FQ) lung scan or CT pulmonary angiography\n* Patients listed for lung or heart-lung transplantation at time of screening\n* Patients on any PAH-specific drug therapy at any time preceding randomisation\n* Known moderate-to-severe restrictive lung disease (i.e., total lung capacity \\\u003C 60% of predicted value) or obstructive lung disease (i.e., forced expiratory volume in one second \\[FEV1\\] \\\u003C 60% of predicted, with FEV1 \u002F forced vital capacity \\\u003C 65%) or known significant chronic lung disease diagnosed by chest imaging (e.g., interstitial lung disease, emphysema).\n* Known or suspected pulmonary veno-occlusive disease (PVOD)\n* Severe renal insufficiency (creatinine clearance \\\u003C 30 mL\u002Fmin)\n* Documented severe hepatic impairment (with or without cirrhosis) according to National Cancer Institute organ dysfunction working group criteria, defined as total bilirubin \\> 3 x ULN or serum AST and\u002For ALT \\> 3xULN (assessed by local laboratory at screening) and\u002For Child-Pugh Class C.\n* Haemoglobin \\\u003C 10 g\u002FdL\n* Patient under guardianship curatorship, deprived of liberty\n* Pregnant women, or breast-feeding women\n* Treatment with other PDE-5i for erectile dysfunction\n* Ongoing or planned treatment with nitrates and\u002For doxazosin.\n* Ongoing or planned treatment with riociguat\n* Treatment with strong inducers of CYP3A4 (e.g., carbamazepine, rifampin, rifampicin, rifabutin, rifapentin, phenobarbital, phenytoin, and St. John's wort) ≤28 days preceding randomisation","ALL","18 Years",{"count":20,"type":21},186,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Pulmonary arterial hypertension (PAH) is a rare, progressive disease associated with poor prognosis, especially in patients with cardiovascular comorbidities. Current guidelines recommend initial combination therapy, but evidence is lacking for patients with significant comorbidities who are often excluded from clinical trials.\n\nThe COMMODITIES trial is a multicenter, randomized, controlled study designed to compare the efficacy and safety of initial dual oral combination therapy (tadalafil and ambrisentan) versus oral monotherapy in newly diagnosed PAH patients with at least two cardiovascular comorbidities. The study aims to provide robust evidence to guide treatment strategies in this high-risk population.",[27,28,29],"Pulmonary Arterial Hypertension (PAH)","Comorbidities","Cardiovascular Disease (CVD)",[31,32,33,34,35,36,37],"PAH","Endothelin Receptor Antagonist (Ambrisentan)","Phosphodiesterase-5 Inhibitor (Tadalafil)","Cardiovascular Comorbidities","Combination Therapy","Randomized Controlled Trial","Pulmonary arterial hypertension","RECRUITING","2026-05-12",{"date":41,"type":42},"2026-05-13","ACTUAL",{"date":44,"type":42},"2026-04-28",{"date":46,"type":21},"2029-02-14",{"name":48,"class":49},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":61,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":50},"100625305","study-of-the-progression-of-chronic-cardiovascular-conditions-100625305","NCT07420907","Study of the Progression of Chronic Cardiovascular Conditions","A Non-interventional Observational Study of the Sustained Use of Prolaio Digital Health Devices to Monitor the Natural History of Chronic Cardiovascular Conditions in Ambulatory Patients","OCORO","Inclusion Criteria:\n\n* 18 years of age and older\n* Ability to understand study assessments and give informed consent to data collection\n* Ability to comply with the study protocol\n* Ability to understand and respond to instructions in English\n* Has diagnosis of qualifying Cardiovascular Disease(s) (CVD) including but not limited to: HF, AS, HCM, HTN, DCM, etc.\n* Resides in the United States\n\nExclusion Criteria:\n\n* Allergy to adhesive used in biosensor patch\n* Life threatening disease process outside of area under study, such as actively treated cancer or pre\u002Fpost-transplant such as hepatic failure; end-stage renal disease.\n* Severe CVD defined by hospital admission for cardiac diagnosis within 30 days of enrollment or documentation of NYHA functional class IV\n* Self-reported weight of 400 pounds or greater",{"count":60,"type":21},5000,"5 Years","OBSERVATIONAL","This study will collect physiologic data in patients with cardiovascular conditions and observe the natural history of those conditions for research purposes.",[29,65,66,67,68,69,70,71,72,73,74,75],"Heart Failure","Aortic Stenosis","Aortic Stenosis Disease","Hypertension","Hypertension (HTN)","Hypertrophic Cardiomyopathy Patients","Hypertrophic Cardiomyopathy Without Obstruction","Hypertrophic Cardiomyopathy, Obstructive","Dilated Cardiomyopathy (DCM)","Dilated Cardiomyopathy","Dilated Cardiomyopathy, Familial","2026-02-16",{"date":78,"type":42},"2026-02-19",{"date":80,"type":42},"2025-10-30",{"date":82,"type":21},"2030-10",{"name":84,"class":85},"Prolaio","INDUSTRY",{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":96,"conditions":97,"keywords":104,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":50},"100607391","cardiovascular-health-of-transgender-individuals-during-the-gender-affirming-pathway-100607391","NCT07187947","Cardiovascular Health of Transgender Individuals During the Gender-affirming Pathway","Cardiovascular Health of Transgender Individuals During the Clinical Gender-affirming Pathway","CV-TGD","Inclusion Criteria:\n\n* Diagnosis of gender incongruence\n* Age 18 years or older at the start of therapy\n* Undergoing gender-affirming (replacement or suppressive) hormone therapy with testosterone or with estradiol plus anti-androgens for at least 12 months\n* Provision of informed consent for study participation and for the processing of personal and sensitive data\n\nExclusion Criteria:\n\n* Any hormone therapy received before recruitment\n* History of cardiovascular events prior to the initiation of hormone therapy",{"count":95,"type":21},500,"Gender incongruence, now classified in ICD-11 as a \"marked and persistent incongruence between an individual's experienced gender and the gender assigned at birth,\" is managed in dedicated, multidisciplinary centres that coordinate psychological support with medical-surgical care.\n\nGender-affirming hormone therapy (GAHT) is central to this care pathway. In particular, masculinising GAHT for people assigned female at birth (AFAB) relies mainly on testosterone, and feminising or demasculinising GAHT for people assigned male at birth (AMAB) combines oestradiol with androgen-lowering agents such as cyproterone acetate or GnRH analogues (triptorelin, leuprorelin). In addition, Gender-affirming surgery (GAS) offers further individualised options: \"Top\" procedures- chest masculinisation for AFAB or breast augmentation for AMAB, and \"Bottom\" procedures\\*\\* such as hysterectomy with or without oophorectomy, phalloplasty or metoidioplasty for AFAB; orchiectomy or vaginoplasty for AMAB. Other ancillary interventions include facial feminisation or voice surgery.\n\nGAHT aims to suppress endogenous sex-hormone levels and secondary sex characteristics while inducing those consistent with the affirmed gender. Despite its widespread use, cardiovascular (CV) safety data are scant and largely observational. Sex-steroid receptors are ubiquitous in the vasculature and contribute to the sex-dimorphic patterns of CV risk seen in cisgender populations; GAHT is therefore biologically plausible as a modifier of CV outcomes in transgender people, yet robust evidence remains limited.\n\nCurrent literature suggests that AFAB individuals on testosterone exhibit an up to 2.66-fold higher composite CV risk than cisgender AFAB comparators. The most consistent changes are higher blood pressure and lower HDL cholesterol; clinically significant polycythaemia is uncommon and treatable. Instead, AMAB individuals on feminising therapy do not show a clearly increased overall CV risk compared with cisgender AMAB peers, though data are inconsistent. An observational study reported that within four months of GAHT initiation, systolic blood pressure rose by 2.6 mmHg in trans men and fell by 4 mmHg in trans women, with no diastolic change in either group.\n\nThe current evidence base is weakened by small cohorts, inadequate control groups, and reliance on surrogate biochemical markers rather than hard clinical endpoints. Many studies also overlook GAHT exposure altogether, hampering meaningful interpretation. Moreover, social determinants-mental-health burden, substance use, and healthcare inequities-compound CV risk but are seldom accounted for.\n\nKey unanswered questions include the long-term CV effects of GAHT, age-specific interactions with blood pressure and lipids, optimal therapeutic targets, and underlying mechanisms. Addressing these gaps demands rigorously designed, large-scale, prospective studies that actively involve transgender participants.\n\nIn summary, while GAHT is indispensable for gender affirmation, its cardiovascular implications-especially for AFAB individuals-warrant caution and systematic monitoring. Future evidence should inform tailored protocols that balance gender-affirming benefits against potential CV risks and integrate biomedical parameters with the broader social context impacting transgender health.",[98,99,100,101,102,29,103],"Gender Incongruence","Cardiovascular (CV) Risk","Cardiovascular Disease Risk Factor","Cardiovascular Disease Acute","Cardiovascular Health Status","Cardiovascular Disease Prevention",[105,106,107,108,109],"cardiovascular risk","transgender","GAHT","GAS","hormones","2025-09-19",{"date":112,"type":42},"2025-09-23",{"date":114,"type":42},"2025-07-18",{"date":116,"type":21},"2035-12-31",{"name":118,"class":49},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":127,"minAge":128,"maxAge":4,"enrollmentInfo":129,"targetDuration":61,"studyType":62,"phases":4,"briefSummary":131,"conditions":132,"keywords":135,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":50},"100357753","womens-advanced-risk-assessment-in-manitoba-100357753","NCT03938155","Women's Advanced Risk-assessment in Manitoba","Women's Advanced Risk-assessment in Manitoba (WARM) Hearts - Examining Cardiovascular Disease Risk in Middle Aged and Older Women","WARM","Inclusion Criteria:\n\n* women aged 55 and older\n* possess a Manitoba Personal Health Information Number\n\nExclusion Criteria:\n\nPrevious hospitalization or treatment for:\n\n* Ischemic heart disease\n* Acute myocardial infarction\n* Stroke\u002FTransient ischemic attack\n* Percutaneous coronary intervention\n* Coronary artery bypass surgery\n* Congestive heart failure\n* Peripheral artery disease\n* Congenital heart defects\n* Arrhythmia\n\nAdditional exclusion:\n\n* Medical advice against physical activity\n* Previous participant in the Assessment of Large and Small Artery Elasticity for the Early Detection of Cardiovascular Disease (NCT02863211)","FEMALE","55 Years",{"count":130,"type":21},1000,"The main objective of this study is to test the ability of novel cardiovascular disease (CVD) prognostic tools to identify women at risk for future CVD. We plan to establish a cardiovascular health screening program at the St. Boniface Hospital and to test the efficacy of these tests for predicting adverse cardiovascular outcomes amongst a cohort of 1000 Manitoban women aged 55 years and older in the 5-year period after screening.\n\nA second purpose of this project is to identify novel CVD biomarkers that may indicate a person is at risk for cardiovascular disease. Therefore, we plan to ask participants for permission to collect and store a sample of both their blood and stool for future research.",[29,133,134],"Cardiovascular Risk Factor","Vascular Stiffness",[136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161],"female","humans","aged","cardiovascular system","cardiovascular diseases","cardiovascular diseases\u002Fepidemiology","early diagnosis","frailty","frailty elderly","prospective studies","Manitoba\u002Fepidemiology","gastrointestinal microbiome","cohort studies","cause of death","risk assessment","biomarkers","risk factors","pulse wave analysis","accelerometry","exercise","physical fitness","gender","sex","women","early detection","screening program","2021-01-25",{"date":164,"type":42},"2021-01-28",{"date":166,"type":42},"2019-10-01",{"date":168,"type":21},"2026-10",{"name":170,"class":49},"St. Boniface Hospital"]