[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiovascular-disease-prevention\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiovascular-disease-prevention":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,50,87,115,152,188,220],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100609948","phase-2-glp-1-receptor-agonists-to-decrease-ethanol-and-cvd-risk-in-hiv-100609948",false,"NCT07221214","GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV","GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV - GL1DER HIV RCT","GL1DER HIV RCT","Inclusion Criteria:\n\n* Ages 18-89\n* Prior diagnosis of HIV-1\n* Affiliated with Vanderbilt Comprehensive Care Clinic\n* On current ART regimen for at least 90 days prior to study entry with no missed doses for at least 7 consecutive days.\n* Most recent absolute CD4 count ≥ 300 cells\u002Fmm3 and drawn within 12 months of study enrollment\n* BMI ≥ 23 (calculated at screening)\n* Self-report of consuming alcohol in past 90 days\n* AUDIT-C ≥ 3 (male)\u002F ≥ 2 (female)\n* Has an established stable address at which they can receive mail and can be reached for the next 6 months\n* Willing and able to complete study procedures and follow-ups\n\nExclusion Criteria:\n\n* Known allergy to semaglutide\n* Currently taking GLP-1 RA (in the past 3 months)\n* History of diabetes defined by diagnosis in Problems List in medical record\n* History of pancreatitis\n* History of gastroparesis\n* Gallbladder disease (in the past 3 months)\n* History of medullary thyroid carcinoma\n* Family history of medullary thyroid carcinoma\n* History of multiple endocrine neoplasia syndrome type 2\n* Family history of multiple endocrine neoplasia syndrome type 2\n* Cognitive inability to consent\n* Barrier to speaking, hearing, reading, or writing English\n* Pregnant or breastfeeding, or planning to become pregnant in the next 6 months\n* Too ill to complete study procedures","ALL","18 Years","89 Years",{"count":21,"type":22},200,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The goal of this clinical trial is to learn if the drug semaglutide works to reduce alcohol intake among adults living with HIV. The main questions it aims to answer are:\n\n1. Does semaglutide lower the average number of alcoholic beverages participants drink per week?\n2. Does semaglutide lower the average number of cigarettes participants smoke per day?\n3. Does semaglutide decrease the risk for cardiovascular disease among people living with HIV who drink alcohol and\u002For smoke tobacco?\n\nResearchers will compare the effects of semaglutide to a placebo (a look-alike substance that contains no drug) to see if semaglutide works to lower the alcohol intake among participants each week.\n\nParticipants will:\n\n1. Take semaglutide for 3 months\n2. Visit the research clinic 3 times for checkups and tests\n3. Provide blood samples, stool samples, and saliva samples for tests.",[28,29,30,31],"HIV","Alcohol","Smoking Cigarette","Cardiovascular Disease Prevention",[28,33,34,35,36],"alcohol","smoking","tobacco","cardiovascular disease","RECRUITING","2026-05-22",{"date":40,"type":41},"2026-05-26","ACTUAL",{"date":43,"type":41},"2026-04-17",{"date":45,"type":22},"2030-01-31",{"name":47,"class":48},"Vanderbilt University Medical Center","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":71,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":49},"100639290","new-taipei-city-888-digital-medical-ai-platform-for-prevention-and-care-of-the-three-highs-and-cardio-renal-vascular-diseases-100639290","NCT07588256","New Taipei City 888 Digital Medical AI Platform for Prevention and Care of the Three Highs and Cardio-Renal-Vascular Diseases","New Taipei City 888 Digital Medical AI Platform for the Prevention and Treatment of the Three Highs (Hypertension, Hyperglycemia, Hyperlipidemia) and Cardio-Renal-Vascular Diseases: Validation and Implementation Through Large-Scale Cluster Randomized Clinical Trials: T-888-DIGICARE-DREAM","DIGICARE-DREAM","Inclusion Criteria:\n\nI.T-888-DIGICARE：\n\nEligible participants must meet the definition of hypertension and at least one of the following chronic (non-hypertensive) conditions:\n\n1. Hypertension\n\n   * With or without treatment, and meeting one of the following:\n   * Office blood pressure: two consecutive measurements \\>130\u002F80 mmHg\n   * Home blood pressure: weekly average (morning\u002Fevening) \\>130\u002F80 mmHg, or more than half of the weekly measurements exceeding this threshold\n2. Hyperlipidemia\n\n   * With or without treatment, and\n   * LDL-C \\>100 mg\u002FdL (or \\>70 mg\u002FdL in patients with diabetes or established ASCVD)\n3. Diabetes Mellitus\n\n   * With or without treatment, and\n   * HbA1c \\>6.5%\n4. Chronic Kidney Disease (CKD)\n\n   * Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m², and\n   * Urine albumin-to-creatinine ratio (UACR) \\>30 mg\u002Fg\n5. Atherosclerotic Cardiovascular Disease (ASCVD):\n\n   * Including coronary artery disease, cerebrovascular disease, peripheral arterial disease, or aortic pathology\n\nII. DREAM-G:\n\n1. Hypertension\n\n   * With or without treatment, and meeting one of the following:\n   * Office blood pressure: two consecutive measurements \\>130\u002F80 mmHg\n   * Home blood pressure: weekly average (morning\u002Fevening) \\>130\u002F80 mmHg, or more than half of weekly measurements exceeding this threshold\n2. Hyperlipidemia\n\n   * With or without treatment, and\n   * LDL-C \\>100 mg\u002FdL (or \\>70 mg\u002FdL in patients with diabetes or established ASCVD)\n3. Diabetes Mellitus\n\n   * With or without treatment, and\n   * HbA1c \\>6.5%\n4. Chronic Kidney Disease (CKD)\n\n   * Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m², and\n   * Measurable urinary microalbumin-to-creatinine ratio\n5. Atherosclerotic Cardiovascular Disease (ASCVD):\n\n   • Including coronary artery disease, cerebrovascular disease, peripheral arterial disease, or aortic pathology\n\n   Participants must meet at least one of the above chronic disease conditions and:\n6. Untreated Hypertension:\n\n   * Morning home blood pressure (HBP) \\>130\u002F80 mmHg: weekly average (≥4 days) \\>130\u002F80 mmHg,\n   * Or more than half of morning HBP measurements (≥4 days per week) \\>130\u002F80 mmHg\n7. Treated Hypertension:\n\n   * Morning home blood pressure \\>130\u002F80 mmHg: weekly average (≥4 days) \\>130\u002F80 mmHg,\n   * Or more than half of morning HBP measurements (≥4 days per week) \\>130\u002F80 mmHg\n   * Average home blood pressure ≤130\u002F80 mmHg (used to determine treatment strategy)\n\nExclusion Criteria:\n\nI. T-888-DIGICARE\n\n1. Symptomatic heart failure (New York Heart Association functional class II-IV)\n2. End-stage renal disease requiring long-term dialysis\n3. Pregnant women or those planning pregnancy\n\nII. DREAM-G:\n\n1. Life expectancy \\\u003C1 year\n2. End-stage renal disease (ESRD) requiring regular renal replacement therapy, including dialysis, kidney transplantation, or palliative care\n3. Severe liver cirrhosis\n4. Malignancy under active treatment",{"count":59,"type":22},4162,[61],"NA","Non-communicable diseases (NCDs), or chronic diseases, are a major public health burden globally and in Taiwan, and control of the \"three highs\" (hypertension, dyslipidemia, and hyperglycemia) is a national priority. Nearly half of the 10 leading causes of death in Taiwan are directly or indirectly related to atherosclerotic cardiovascular disease (ASCVD), for which hypertension, dyslipidemia, and abnormal blood glucose are the major risk factors. National health insurance data indicate that over 70% of middle-aged and older adults have at least one of these chronic conditions. Early stages are often asymptomatic, and inadequate control may lead to complications of cardiovascular disease, stroke, renal vascular disease, and retinopathy, causing irreversible organ damage and death.\n\nFor blood pressure, large clinical trials such as SPRINT and STEP have shown that targeting systolic blood pressure below 130 mmHg significantly reduces ASCVD events. For LDL cholesterol, \"the lower, the better\" applies, with guideline-recommended LDL-C targets determined by baseline ASCVD risk, with levels below 55 mg\u002FdL for very high-risk patients. For diabetes, treatment goals generally include fasting plasma glucose below 130 mg\u002FdL and glycated hemoglobin (HbA1c) below 7%.\n\nAlthough antihypertensive therapy has been proven effective in preventing cardiovascular disease and chronic kidney disease attributable to hypertension, fewer than one-third of patients receiving antihypertensive medications achieve current guideline-recommended blood pressure targets. No randomized clinical trial to date has used home blood pressure as the primary therapeutic reference. Moreover, long-term evidence is lacking regarding the organ-protective effects of strategies targeting morning hypertension and of bedtime dosing regimens. Although the TIME study is currently the largest and longest-followed trial addressing dosing time, its bedtime-dosing arm was not specifically targeted to patients with morning hypertension. Therefore, we propose a clinical trial to investigate management strategies for morning hypertension. Aligned with the 2022 Taiwan Hypertension Guidelines, we will employ the \"722 protocol\" for home blood pressure monitoring and enroll patients with morning home blood pressure ≥130\u002F80 mmHg to compare selective nocturnal administration of antihypertensive agents versus exclusive morning dosing, assessing differences in morning home blood pressure control rates, end-organ damage, and atherosclerotic cardiovascular disease (ASCVD) events.\n\nThis project will implement two large-scale cluster-randomized clinical trials within the New Taipei City healthcare network. The first trial (T-888-DIGICARE) will evaluate whether a mobile digital health platform augmented with interactive digital modules can more effectively achieve the \"888\" targets for prevention and treatment of the Three Highs (Hypertension, Hyperglycemia, Hyperlipidemia). The second trial (DREAM-G) will use the same mobile health delivery model to investigate whether the timing of antihypertensive medication administration (nocturnal versus morning dosing) differentially affects patients with poor morning home blood pressure control. Beyond generating rigorous evidence through a novel clinical approach, this program is expected to have substantial global clinical impact and to showcase Taiwan's healthcare capabilities internationally. Operational challenges encountered and solutions developed during the trials will also provide critical feasibility data for the concurrent real-world implementation registry (T-888-DIGICARE-Registry). The registry will run in parallel with the cluster trials and will enroll individuals who decline trial participation at baseline as well as participants after trial completion, thereby serving as a continuity and real-world evidence platform.",[64,65,66,31,67,68,69,70],"Microalbuminuria","Microalbuminuria \u002FCreatinine Ratios ACR","Cardiovascular Disease Risk Factor","Digital Medicine","Hypertension","Hyperglycaemia (Diabetic)","Hyperlipidemia",[72,73,74,75,76,77],"digital medicine","hypertension","home blood pressure monitoring","dyslipidemia","microalbuminuria","diabetes","2026-05-11",{"date":80,"type":41},"2026-05-14",{"date":82,"type":41},"2026-02-05",{"date":84,"type":22},"2029-02-05",{"name":86,"class":48},"New Taipei City Medical Association",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100609186","monitoring-and-guidance-of-physical-activity-during-the-maintenance-phase-of-cardiac-rehabilitation-the-antwerp-activity-index-100609186","NCT07211282","Monitoring and Guidance of Physical Activity During the Maintenance Phase of Cardiac Rehabilitation: the Antwerp Activity Index","Transmural Physical Activity Monitoring and Guidance During Phase 3 Cardiac Rehabilitation: the Antwerp Activity Index","AMAAI","Inclusion Criteria:\n\n1. Age ≥ 18 years,\n2. Patients in the last phase of phase 2 CR,\n3. Having a smartphone available,\n4. Being capable of signing the informed consent.\n\nExclusion Criteria:\n\n1. Patients with high-risk criteria for safe exercise participation following a cardiac event, including:\n\n   1. Ejection fraction less than 30%\n   2. Decrease in systolic blood pressure of more than 15 mmHg with exercise\n   3. Serious arrhythmias at rest or exercise-induced\n   4. Exercise-induced ischemia indicated by angina more than 2 mm ST segment depression on the ECG\n2. Patients with severe heart failure (NYHA III-IV),\n3. Patients with implantable devices (e.g. pacemakers),\n4. Patients diagnosed with permanent AF,\n5. Patients who do not speak and read Dutch or English,\n6. Patients who have cognitive impairment (e.g. severe dementia).",{"count":96,"type":22},318,[61],"The goal of this clinical trial is to determine whether the AAI activity score can help cardiac rehabilitation patients adhere to physical activity guidelines after participating in an in-hospital cardiac rehabilitation program. The main questions it aims to answer are:\n\n1. Does the AAI activity score have an impact on adherence to physical activity maintenance during phase 3 CR?\n2. Does the AAI activity score predict changes in cardiorespiratory fitness? Researchers will compare participants who use the AAI activity score with those who do not to determine if there are differences in physical activity adherence.\n\nParticipants will:\n\n* Wear a smartwatch to continuously measure heart rate for 4 months;\n* Perform an exercise stress test at the end of the study;\n* Fill in several questionnaires at the end of the study.",[100,31],"Cardiac Rehabilitation",[102,103,104],"physical activity","cardiac rehabilitation","heart rate monitor","2026-04-30",{"date":107,"type":41},"2026-05-06",{"date":109,"type":41},"2025-02-17",{"date":111,"type":22},"2029-01",{"name":113,"class":48},"University Hospital, Antwerp",2,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":123,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":127,"conditions":128,"keywords":131,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":49},"100623816","assessment-and-prediction-of-cardiovascular-health-and-disease-risk-using-wearable-biometrics-100623816","NCT07401550","Assessment and Prediction of Cardiovascular Health and Disease Risk Using Wearable Biometrics.","Assessment and Prediction of Cardiovascular Health and Disease Risk Using Longitudinal Wearable Biometrics: a Prospective Cohort Study.","BEACON-HEART","Inclusion Criteria:\n\n* Adults aged 18 years, or older\n* Internet access\n* Possession of a smartphone compatible with the Fitbit mobile app\n\nExclusion Criteria:\n\n* Pregnancy\n* Unstable medical condition\n* Inability to provide informed consent\n* Mental or cognitive impairment precluding adherence to study protocol\n* Smartwatch cannot be worn, (e.g., allergic reactions), or cannot be worn in accordance with manufacturer guidelines (e.g., amputation, dark tattoos at wrist)",true,{"count":125,"type":22},100,"OBSERVATIONAL","This prospective, observational cohort study will evaluate the associations between wearable-derived biometrics and cardiovascular health, quantified by the American Heart Association's Life's Essential 8 framework, as well as related cardiovascular risk factors. The study aims to determine whether wearable biometrics can support the assessment of cardiovascular health and cardiovascular disease risk, both when used in isolation and in combination with point-of-care assessments.",[129,31,66,130],"Cardiovascular Diseases (CVD)","Coronary Artery Disease (CAD)",[132,133,134,36,135,136,137,138,139,140,141,142],"wearables","wearable devices","cardiovascular health","wearable technology","fitbit","fitabase","remote monitoring","cardiovascular disease prevention","cardiovascular risk reduction","digital biomarker","coronary artery disease","2026-02-03",{"date":145,"type":41},"2026-02-10",{"date":147,"type":41},"2025-12-09",{"date":149,"type":22},"2026-12",{"name":151,"class":48},"University College Dublin",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":17,"minAge":160,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":23,"phases":164,"briefSummary":165,"conditions":166,"keywords":170,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":49},"100616121","akershus-cardiac-examination-ace-5-study-100616121","NCT07301489","Akershus Cardiac Examination (ACE) 5 Study","Akershus Cardiac Examination (ACE) 5 Study: Pragmatic Randomized Controlled Trial of Lung Cancer Screening Plus Program to Improve Cardiovascular Risk Profile and Health in Individuals With Heavy Smoking History","ACE5","Inclusion Criteria used for the lung cancer screening implementation study\u002F TIDL Study:\n\n* Women and men\n* Ages 60 to 79 years old (inclusive)\n* A smoking history of at least 35 pack-years and 1) being a current smoker or a former smoker who quit less than 10 years prior or 2) having a PLCOm2012 model 6-year risk for lung cancer incidence over 2.6%.\n* Willingness and ability to comply with scheduled visits, laboratory tests, and other trial procedures\n* Written informed consent obtained prior to performing any protocol-related procedures\n* The participant should be affiliated to a social security system\n\nExclusion Criteria used for the lung cancer screening implementation study\u002F TIDL Study:\n\n* Recent abnormal pulmonary findings under work-up of standard care\n* Having had chest CT \\\u003C1 year before potential entry into the study\n* Current or prior history of lung cancer, renal cancer, melanoma or breast cancer\n* Inability to provide signed informed consent\n* Insufficient understanding of the languages in which trial information is available\n* Psychiatric or other disorders that are incompatible with compliance to the protocol requirements and follow-up\n* Unable to be followed-up for at least 5-years\n* Body weight \\>140 Kg because of difficulty of conducting the CT exam\n\nInclusion Criteria used for the ACE 5 Study:\n\n* Participants from the TIDL Study with non-contrast, non-cardiac chest CT images available as part of the implementation lung cancer screening study\n* Signed consent for cardiovascular add on-study and agree to protocol, including follow-up visit 1-year after the baseline examination\n\nExclusion Criteria used for the ACE 5 Study:\n\n* Any surgical or medical condition, including short life-expectancy, based on medical records or clinical findings prior to randomization, that will impair the ability of the patient to participate in the study\n* Patients unwilling or unable to comply with the protocol\n* History of non-compliance to medical management and patients who are considered potentially unreliable, based on information obtained prior to randomization\n* History or evidence of alcohol or drug abuse with the last 12 months, based on information obtained prior to randomization, that will influence study participation","60 Years","79 Years",{"count":163,"type":22},1000,[61],"Individuals with extensive smoking history have 2- to 3-fold increased risk of dying prematurely compared to age- and gender-matched peers. Historical data indicate that 55% of heavy smokers will die from cardiovascular disease (CVD), while approximately 5% will die from lung cancer. Lung cancer screening programs are currently being implemented worldwide, but efforts to reduce also CVD are not included.\n\nThe research group behind the ACE 5 Study are affiliated with the study team behind the implementation study of lung cancer screening in Norway (\"Tidlig oppdagelse av lungekreft \\[TIDL\\]\"). The TIDL Study have performed non-contrast, non-cardiac chest CT-based screening for lung cancer in 1000 individuals. Prior studies have demonstrated that a visual four-group classification of coronary artery calcification using non-contrast, non-cardiac chest CT images provide an easily available, non-invasive surrogate index for subclinical and established chronic coronary syndrome. Accordingly, the 2024 European Society of Cardiology guidelines for chronic coronary syndrome promotes that opportunistic screening for atherosclerotic CVD (ASCVD) should be performed when non-contrast, non-cardiac chest CT images are available (\"IIa recommendation\"). The investigators will now invite TIDL participants for a second study, the Akershus Cardiac Examination (ACE) 5 Study, which will assess whether intervention also against ASCVD (\"Lung Cancer Screening Plus Program\") will improve cardiovascular risk profile and cardiovascular health in individuals with heavy smoking history.\n\nThe ACE 5 Study will be a separate study with separate protocol and consent as the ACE 5 Study will focus on the prevention of CVD in individuals with heavy smoking history as add-on to lung cancer screening. The ACE 5 Study will assess the combined effect of (1) non-contrast, non-cardiac chest CT images as basis for ASCVD detection, and (2) the value of a hospital-based, nurse-led follow-up program to improve cardiovascular risk profile and cardiovascular health in individuals with heavy smoking history. Whether a Lung Cancer Screening Plus Program can improve cardiovascular risk profile and indices of improved cardiovascular health compared to the current strategy\u002Fstandard in individuals with heavy smoking history is currently not known. The primary endpoint relates to status for cardiovascular risk profile after 1-year follow-up, and the study will use pre-defined cutoffs for the different risk factors based on relevant European Society of Cardiology (ESC) Guidelines, especially the 2021 ESC guidelines for primary prevention and the 2024 ESC guidelines for chronic coronary syndrome.",[167,168,169,31],"Heavy Smokers","Lung Cancer Screening","Cardiovascular Risk Profile",[171,172,173,174,175,176,177,178],"Heavy smokers","Lung cancer screening","Cardiovascular risk profile","Cardiovascular disease prevention","Chronic coronary syndrome","Atherosclerotic cardiovascular disease","Non-contrast, non-cardiac chest CT-based screening","Nurse-led follow-up program","2025-12-10",{"date":181,"type":41},"2025-12-24",{"date":183,"type":41},"2025-10-01",{"date":185,"type":22},"2041-04",{"name":187,"class":48},"University Hospital, Akershus",{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":198,"conditions":199,"keywords":205,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":49},"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":197,"type":22},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.",[200,201,66,202,203,204,31],"Gender Incongruence","Cardiovascular (CV) Risk","Cardiovascular Disease Acute","Cardiovascular Health Status","Cardiovascular Disease (CVD)",[206,207,208,209,210],"cardiovascular risk","transgender","GAHT","GAS","hormones","2025-09-19",{"date":213,"type":41},"2025-09-23",{"date":215,"type":41},"2025-07-18",{"date":217,"type":22},"2035-12-31",{"name":219,"class":48},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":17,"minAge":228,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":231,"briefSummary":232,"conditions":233,"keywords":240,"overallStatus":244,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":49},"100585834","preventative-screening-and-health-coaching-in-a-food-insecure-population-100585834","NCT06907524","Preventative Screening and Health Coaching in a Food Insecure Population","Community-Based Preventative Cardiometabolic Screening and Health Coaching- A Prospective Study","HEALTHCOACH","Inclusion:\n\nPatient is a participant at a CHI sponsored, community screening event Patient provides informed consent and willingness to participate for the duration of the study English or Spanish speaking Age 40-75 years old At least 1 cardiometabolic risk factor at suboptimal level\n\nDefined as one or more of the following at initial screening:\n\nBlood Pressure (BP):\n\nSystolic BP greater than 130mmHg and\u002For diastolic BP greater than 80mmHg. Obesity: body mass index (BMI) greater than 30 〖kg\u002Fm〗\\^2\n\nDyslipidemia:\n\nTotal cholesterol greater than 200 mg\u002FdL Triglycerides greater than 150 mg\u002FdL Low density lipoprotein (LDL) greater than 130 mg\u002FdL High density lipoprotein (HDL) less than 40 mg\u002FdL in men or less than 50 mg\u002FdL in women Hemoglobin A1c greater than or equal to 5.7% 10-year ASCVD score greater than 5% Access to a telehealth compatible device\n\nExclusion:\n\nAdults unable to provide informed consent or unwilling to participate for study duration Speaks language other than English or Spanish Younger than 40 years old or older than 75 years old All cardiometabolic risk factors at optimal levels No telehealth compatible device Pregnant patients","40 Years","75 Years",{"count":21,"type":22},[61],"The goal of this longitudinal study is to investigate the role of virtual health coaching on mitigation of cardiometabolic disease risk in an underserved, food insecure population. The main questions it aims to answer are:\n\n* Does longitudinal, individualized health coaching directed at lifestyle modification reduce patient 10-year risk of heart attack or stroke?\n* Does longitudinal, individualized health coaching directed at lifestyle modification reduce rates of hypertension, hyperlipidemia, and diabetes?\n* Does longitudinal, individualized health coaching directed at lifestyle modification improve accessibility to healthcare?\n\nResearchers will investigate the effects of regularly scheduled health coaching sessions on composite cardiometabolic risk profile as well as individual modifiable cardiovascular risk factors.\n\nParticipants will:\n\n* Participate in in-person cardiovascular screening, occuring at the time of enrollment, months 3 and 6.\n* Engage in virtual health coaching sessions to talk about diet, exercise, weight loss, blood pressure and diabetes control, and accessibility to healthcare\n* Keep a log of their blood pressure",[31,234,235,236,68,70,237,238,239],"Cardiometabolic Diseases","Cardiovascular Risk Factor","Cardiovascular Risk Score","Diabetes","Lifestyle Modification","Health Coaching",[31,241,68,70,237,238,239,236,242,235,243],"Cardiometabolic Disease Screening","Atherosclerotic Cardiovascular Disease Risk Score","Cardiometabolic Disease","NOT_YET_RECRUITING","2025-03-26",{"date":247,"type":41},"2025-04-02",{"date":249,"type":22},"2025-04-01",{"date":251,"type":22},"2027-07-01",{"name":253,"class":48},"Rush University Medical Center"]