[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiovascular-complication\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiovascular-complication":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,41,75,104,132,157,189,220,253,281,318,340,362,393,415],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100480091","bariatric-surgery-for-the-reduction-of-cardiovascular-events-randomized-controlled-trial-100480091",false,"NCT05531474","Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial","BRAVE","Inclusion Criteria:\n\n1. Body mass index ≥30 kg\u002Fm2; OR BMI ≥30 kg\u002Fm2 to 34.9 kg\u002Fm2 and have type 2 diabetes or are \\>55 years of age\n2. Age ≥18 years\n3. High-risk CVD, defined as the presence of any one of the following:\n\n   1. High-risk coronary artery disease (CAD) (i.e., history of MI, percutaneous coronary intervention, coronary artery bypass grafting, or stenoses ≥ 50% in 2 or more major coronary arteries)\n   2. Left ventricular ejection fraction (LVEF) \\< 40%\n   3. Heart failure with preserved ejection fraction (LVEF \\> 40%) and either HF hospitalization in the last 2-years or N-terminal pro b-type natriuretic peptide (NT-proBNP) \\> 300 pg\u002Fml or BNP \\> 100 pg\u002Fml in the past 12 months\n   4. Documented atrial fibrillation (AF) with CHA2DS2-VASc ≥2 stroke risk score\n   5. History of any stroke\n   6. Documented peripheral arterial disease (PAD) (i.e., peripheral revascularization of the iliac, infra-inguinal or carotid arteries; limb or foot amputation for arterial vascular disease; or ≥50% carotid or peripheral artery stenosis)\n\nExclusion Criteria:\n\n1. Hospital admission for HF, myocardial infarction, stroke or coronary revascularization within 30 days of randomization\n2. Percutaneous coronary intervention with a drug eluting stent within 90 days of randomization.\n3. Pregnancy\n4. Contraindication to bariatric surgery\n5. Prior bariatric surgery, other than gastric banding\n6. Life expectancy \\<2 years from non-cardiovascular causes\n7. Inability to provide informed consent","ALL","18 Years",{"count":19,"type":20},700,"ESTIMATED","INTERVENTIONAL",[23],"NA","The primary objective of this study is to evaluate if, in patients with severe obesity (body mass index (BMI) ≥30 kg\u002Fm2) and high-risk cardiovascular disease (CVD), bariatric surgery compared to medical weight management (MWM) safely reduces the risk of major cardiovascular events. The cost-effectiveness of bariatric surgery will also be examined. Separate sub-studies will be performed to examine the relationship between bariatric surgery and mental health and cognition (BRAVE-Mind), cardiac structure and function, genomics, proteomics and metabolomics.",[26,27],"Cardiovascular Complication","Bariatric Surgery Candidate","RECRUITING","2026-05-25",{"date":31,"type":32},"2026-05-28","ACTUAL",{"date":34,"type":32},"2020-11-02",{"date":36,"type":20},"2027-07-01",{"name":38,"class":39},"Population Health Research Institute","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":40},"100576424","phase-4-a-randomized-placebo-controlled-trial-of-dapagliflozin-dapa-for-cardiovascular-risk-reduction-in-the-postpartum-period-of-hypertensive-pregnancies-hp-100576424","NCT06785116","A Randomized, Placebo-controlled Trial of DAPAgliflozin (DAPA) for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies (HP)","A Randomized, Placebo-controlled Trial of DAPAgliflozin for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies","DAPA-HP","Inclusion Criteria:\n\n* Admitted for delivery at the University of Michigan (UM) Labor and Delivery (L\\&D) unit or enrolled in the UM postpartum blood pressure monitoring program following a delivery at the UM L\\&D unit\n* Determined to be at least 23 and 0\u002F7 weeks of gestation based on a clinically acceptable dating method (can be a single or multifetal gestation with or without the presence of fetal anomalies) at the time of delivery\n* Consents to participation and must understand\u002Fread\u002Fspeak English with the ability to understand and willingness to sign a written informed consent in English\n* Diagnosed with a hypertensive pregnancy by either of the following criteria:\n\n  * Taking an antihypertensive medication for the diagnosis of chronic or essential hypertension at the time of admission\n  * Hypertension, chronic hypertension, or essential hypertension must be present in the prospective participant's medical record\n  * Antihypertensive\" can be any medication taken for the purpose of blood pressure control per the medical record\n  * A documented hypertensive disorder of pregnancy (gestational hypertension, preeclampsia without severe features, preeclampsia with severe features, superimposed preeclampsia, or eclampsia) prior to delivery\n* Eligible participants must report a planned contraceptive method as part of the consent process, to be noted on their consent document.\n* Has two or more blood pressures ≥160\u002F110 Millimeters of mercury (mmHg) at least 60 minutes apart\n\n  * If an admitted patient does not meet this blood pressure criterion but is otherwise eligible, participants can consent to have a BNP drawn within 12 hours of delivery as an alternative measure of cardiovascular risk (if the brain natriuretic peptide (BNP) is ≥100 Picograms per milliliter (pg\u002Fml), participants are eligible to participate)\n\nExclusion Criteria:\n\n* Non-English speaking\n* Ongoing pregnancy\n* Stated desire to become pregnant within 8 months post-delivery\n* Intention to breastfeed after enrollment\n* BNP ≥1000 pg\u002Fml within 12 hours of delivery, clinical team to be notified of result\n* Comorbidities that may affect cardiovascular risk assessment (per protocol)\n* Contraindication to dapagliflozin (per protocol)","FEMALE",{"count":51,"type":20},200,[53],"PHASE4","This trial is a pilot-scale, single institution randomized, placebo-controlled trial to assess the feasibility, acceptability, and efficacy of administering dapagliflozin for cardiovascular risk reduction in the postpartum period. The target population is patients at high risk of adverse cardiovascular outcomes within five years post-delivery.\n\nEligible participants will be randomized to receive either: 1) dapagliflozin (10mg daily) for six months (DAPA group) or 2) an orally administered, daily placebo (Control group).\n\nThe study hypothesizes:\n\nThe dapagliflozin group will have higher cardiovascular risk reduction scores than the Control Group.",[56,57,58,59,26],"Gestational Hypertension","Hypertension in Pregnancy","Pre-Eclampsia","Superimposed Pre-Eclampsia",[61,62,63,64,65],"Medication","Placebo","Postpartum period","Cardiovascular risk reduction","Echocardiogram","2026-03-01",{"date":68,"type":32},"2026-03-04",{"date":70,"type":32},"2025-03-02",{"date":72,"type":20},"2028-08",{"name":74,"class":39},"University of Michigan",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":4},"100624340","early-diagnosis-and-cardiovascular-risk-stratification-in-children-exposed-to-cancer-therapies-100624340","NCT07408362","Early Diagnosis and Cardiovascular Risk Stratification in Children Exposed to Cancer Therapies","How to Improve Early Diagnosis and Cardiovascular Risk Stratification in Children Exposed to Chemotherapy and\u002For Thoracic Radiotherapy? Multimodal Cardiological Evaluation and Biomarkers.","CTRCT-pedia","Inclusion Criteria:\n\n* History of chemotherapy and\u002For radiotherapy for an oncological condition or bone marrow transplantation (hematologic disease) after 01\u002F01\u002F2016.\n* Age \\\u003C 18 years at the time of treatment.\n* Cancer remission for more than one year.\n* Voluntary participation following comprehensive informed consent.\n* Signed informed consent from the patient (≥ 18 years) or from parents\u002Flegal guardians, with signed assent for minors aged 8 to 17.\n\nExclusion Criteria:\n\n* Active disease recurrence or relapse.\n* Current administration of antineoplastic therapy.\n* Withdrawal of consent or refusal to participate by the patient or their legal representatives.","2 Years","25 Years",{"count":86,"type":20},100,[23],"The goal of this prospective interventional study is to improve the detection of subclinical chronic Cancer Therapy-Related Cardiovascular Toxicity (CTRCT) and evaluate the added value of advanced cardioechography, ergospirometry, and specific biomarkers in pediatric cancer survivors (aged 2 to 25) who received potentially cardiotoxic treatments (chemotherapy\u002Fthoracic radiotherapy). The main questions it aims to answer are:\n\n* Can advanced echocardiography (including strain and myocardial work), ECG, and ergospirometry effectively diagnose earlier subclinical cardiac impairment in this population?\n* What is the prevalence of cardiovascular risk factors (including physical activity levels and biological markers like proBNP\u002Ftroponins)\n* Can new genetic or biological markers be identified to help optimizing the detection of CTRCT?\n\nAt time of follow-up, if they agree, participants will:\n\n* Complete validated questionnaires regarding quality of life, physical activity, and sedentary behavior.\n* Undergo a cardiopulmonary exercise test (ergospirometry) for those aged over 8 years.\n* Wear an accelerometer (ActiGraph GT3X) for 7 consecutive days to monitor physical activity.\n* Provide an additional blood sample during routine follow-up for the creation of a biobank dedicated to analyzing markers of senescence, fibrosis, apoptosis, and genetic polymorphisms.",[90,91,92,93,26],"Cancer Therapy-related Cardiovascular Toxicity","Childhood Cancer","Chemotherapeutic Toxicity","Radiotherapy Side Effect","NOT_YET_RECRUITING","2026-02-10",{"date":97,"type":32},"2026-02-13",{"date":99,"type":20},"2026-02-15",{"date":101,"type":20},"2033-12-31",{"name":103,"class":39},"Centre Hospitalier Universitaire de Liege",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":40},"100437779","phase-3-early-specialized-cardiovascular-intervention-based-on-impedance-cardiography-in-locally-advanced-non-small-cell-lung-cancer-patients-100437779","NCT04980716","Early Specialized Cardiovascular Intervention Based on Impedance Cardiography in Locally Advanced Non-small Cell Lung Cancer Patients","Early Specialized Cardiovascular Intervention Based on Impedance Cardiography in Locally Advanced Non-small Cell Lung Cancer Patients Who Receiving Radical Concurrent Chemoradiotherapy and Immunotherapy: a Prospective, Randomized Controlled, Multicenter Phase III Clinical Trial.","Inclusion Criteria:\n\n1. It is diagnosed as non-small cell lung cancer by pathological examination or cytological examination; it is assessed as locally advanced, unresectable stage III non-small cell lung cancer by imaging;\n2. Plan to receive radical radiotherapy and chemotherapy ± immunotherapy;\n3. Male or female between 18 and 75 years old;\n4. Life expectancy ≥ 12 weeks;\n5. The World Health Organization (WHO) PS score is 0 or 1;\n6. Organ and bone marrow function meet the following conditions: Forced expiratory volume per second (FEV1) ≥1000 ml; absolute neutrophil count ≥1.5×10\\^9\u002FL; platelets ≥100×10\\^9\u002FL; hemoglobin ≥90 g\u002FL ; Serum creatinine clearance calculated according to the Cockcroft-Gault formula ≥50 mL\u002Fmin (Cockcroft and Gault 1976); serum bilirubin ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase ≤2.5 times ULN;\n7. A signed informed consent form is required before proceeding with any step in the research;\n8. There is an abnormality in the initial cardiac output index.\n\nExclusion Criteria:\n\n1. PS score 2-4;\n2. Organ function impairment: FEV1 \\\u003C1000ml; absolute neutrophil count \\\u003C1.5×10\\^9\u002FL; platelets \\\u003C100×10\\^9\u002FL; hemoglobin \\\u003C90 g\u002F L; Serum creatinine clearance calculated according to Cockcroft-Gault formula \\\u003C50 mL\u002Fmin; serum bilirubin\\>1.5 times ULN; alanine aminotransferase and aspartate aminotransferase\\>2.5 times ULN;\n3. Unstable angina or myocardial infarction occurred in the past month;\n4. Arrhythmia that has not been controlled and can cause symptoms or abnormal hemodynamics;\n5. Active endocarditis;\n6. Symptomatic severe aortic stenosis;\n7. Heart failure that has not been controlled;\n8. Acute pulmonary embolism, pulmonary infarction or low thrombosis (artery or vein) formation;\n9. Suspected or confirmed aortic dissection;\n10. Uncontrolled bronchial asthma;\n11. Pulmonary edema;\n12. Fingertip blood oxygen saturation at rest ≤85%;\n13. Acute non-cardiopulmonary diseases (such as infection, renal failure, thyrotoxicosis, etc.) that may affect sports performance or aggravate due to exercise;\n14. Mental disorders make it impossible to cooperate.\n15. Patients for whom drug intervention is clearly recommended according to the 2022 edition of the European Society of Cardiology Guidelines on Cardio-Oncology.","75 Years",{"count":113,"type":20},524,[115],"PHASE3","This is a prospective, randomized, controlled, multi-center phase III clinical trial that intends to evaluate the role of early cardiovascular intervention based on impedance cardiography in patients with locally advanced non-small cell lung cancer receiving radical radiochemotherapy±immunotherapy.",[118,26],"Non-small Cell Lung Cancer",[118,120,121,122],"Cardiovascular Intervention","Impedance Cardiography","Cardiovascular Event","2025-11-14",{"date":125,"type":32},"2025-11-18",{"date":127,"type":32},"2021-06-01",{"date":129,"type":20},"2026-07-01",{"name":131,"class":39},"Sun Yat-sen University",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":140,"enrollmentInfo":141,"targetDuration":143,"studyType":144,"phases":4,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":153,"leadSponsor":155,"locationsCount":4},"100608337","cardiovascular-complications-after-adrenalectomy-for-pheochromocytoma-and-non-secreting-tumors-100608337","NCT07200245","Cardiovascular Complications After Adrenalectomy for Pheochromocytoma and Non-secreting Tumors","Cardiovascular Complications After Adrenalectomy for Pheochromocytoma and Non-secreting Tumors - A Prospective Observational Multicenter European Study (HEMODYNAMICS)","HEMODYNAMICS","Inclusion Criteria:\n\n* Patients undergoing adrenalectomy for pheochromocytoma\n* Patients undergoing adrenalectomy for non-secreting tumors. Patients with non-secreting tumors are those with indication for adrenalectomy in the Eurocrine database corresponding to \" excluding malignancy \".\n\nExclusion Criteria:\n\n* Children and minors (\\\u003C18 years).\n* Pregnant women.\n* Patients with other indication for adrenalectomy in Eurocrine (i.e. Adrenocortical cancer, Cushing, Primary aldosteronism, Metastasis).","100 Years",{"count":142,"type":20},522,"30 Days","OBSERVATIONAL","Pheochromocytoma is an adrenomedullary chromaffin cell tumour that releases catecholamines. Adverse cardiovascular events are considered the main cause of morbidity and mortality in patients with pheochromocytoma. Consequently, preoperative medical preparations using alpha-blockers or other antihypertensive drugs and the control of hemodynamic instability during adrenalectomy for pheochromocytoma are recommended by guidelines to prevent vasoconstriction, perioperative cardiovascular complications, and the risk of death. However, the definition of a catecholamine-induced hypertensive crisis in patients with pheochromocytoma has only recently been validated by an international consortium as the occurrence of systolic\u002Fdiastolic blood pressure \\>180\u002F120 mmHg1. Limitations of published studies include small sample sizes, and single institution analysis. Some studies have reported substantial variability in the management of pheochromocytomas, with the use of routine preoperative medical preparation varying from 49% to 100%, whereas others have questioned the utility of this preparation for postoperative cardiovascular complications. The aim of this study was to evaluate pan-European practices in terms of specific preoperative medical preparation before surgery and to identify risk factors for postoperative cardiovascular complications 30 days after adrenalectomy for pheochromocytoma and non-secreting tumors (indication for surgery = \" excluding malignancy \").\n\nThe EUROCRINE® registry offers a valuable opportunity to assess clinical practices for preoperative medical preparation and the morbidity linked to adrenalectomy for pheochromocytoma and non-secreting tumors. This prospective study aims to refine surgical protocols and inform updates to existing guidelines, thereby advancing the management of adrenalectomy for pheochromocytoma.",[147,26,148],"Pheochromocytoma","Adrenal Incidentaloma","2025-09-22",{"date":151,"type":32},"2025-10-01",{"date":151,"type":20},{"date":154,"type":20},"2027-12-31",{"name":156,"class":39},"Central Hospital, Nancy, France",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":167,"conditions":168,"keywords":174,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":40},"100606672","clinical-determinants-and-adverse-reactions-to-tropicamidephenylephrine-in-hospitalized-patients-100606672","NCT07178600","Clinical Determinants and Adverse Reactions to Tropicamide\u002FPhenylephrine in Hospitalized Patients.","Characterization and Association of Clinical Determinants With the Occurrence of Adverse Drug Reactions Following the Administration of Tropicamide\u002FPhenylephrine in Hospitalized Patients.","RAM-TF-IOCV","Inclusion Criteria:\n\n* Patients who have authorized participation in the study by signing informed consent.\n* Patients over 18 years of age.\n* Any sex.\n* Patients from the \"Instituto de Oftalmología Conde de Valenciana, IAP., sede Centro\" who have been scheduled for a surgical procedure.\n* Patients for whom the administration of two drops of tropicamide\u002Fphenylephrine 8 mg\u002F50 mg\u002FmL is indicated.\n* Patients that presents any type of disease\n\nExclusion Criteria:\n\n* Allergy to any component of the formulation.",{"count":166,"type":20},1000,"To evaluate the association between clinical determinants and the occurrence of adverse drug reactions in hospitalized patients who received tropicamide\u002Fphenylephrine 8 mg\u002F50 mg\u002FmL.\n\nAn ambispective, interventional, longitudinal study will be conducted to actively identify adverse reactions to tropicamide\u002Fphenylephrine 8 mg\u002F50 mg\u002FmL, as well as the clinical determinants that may predispose patients to the occurrence of an adverse drug reaction (ADR). Data will be collected through the administration of a questionnaire and measurement of vital signs prior to the administration of tropicamide\u002Fphenylephrine 8 mg\u002F50 mg\u002FmL, and subsequently at 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours after administration, with the aim of establishing an association between these variables.",[169,170,171,26,172,173],"Adverse Drug Effect","Phenylephrine","Hypertension","Ophthalmology","Ocular Discomfort",[169,175,176,177,178,171,172,179],"Tropicamide\u002Fphenylefrine","Tropicamide","Phenylefrine","Cardiovascular complications","Ocular discomfort","2025-09-11",{"date":182,"type":32},"2025-09-17",{"date":184,"type":32},"2023-09-02",{"date":186,"type":20},"2026-09",{"name":188,"class":39},"Instituto de Oftalmología Fundación Conde de Valenciana",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":197,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":21,"phases":200,"briefSummary":201,"conditions":202,"keywords":205,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":219},"100466148","effects-and-safety-of-diabetic-guideline-algorithm-implementation-performed-by-primary-care-physicians-in-the-community-100466148","NCT05349955","Effects and Safety of Diabetic GUideline Algorithm Implementation Performed by Primary Care Physicians in the Community","Effects and Safety of GUideline Algorithm Based Intervention on CaRdiovascular and Renal Outcomes in Elderly Diabetic Patients With High Cardiovascular Risk in the Community- A Cluster Randomized Controlled Trial (GUARD-Community Study)","GUARD","Inclusion Criteria:\n\n* ①Males or females aged 65 and above (≥65) receive treatment from the local community health service center;\n* ②Diagnosed type 2 diabetes (ADA criteria):\n* A. Typical symptoms of diabetes + random blood sugar ≥ 11.1mmol\u002FL;\n* B. Fasting blood glucose (FPG) ≥ 7.0mmol\u002FL (fasting blood glucose is defined as no caloric intake within 8 hours);\n* C. Oral glucose tolerance test 2h blood glucose (OGTT) ≥ 11.1mmol\u002FL (2h after meal);\n* D. have been treated with antidiabetic drugs;\n* Each blood sugar test must be repeated to confirm the diagnosis;\n* ③Complicated with chronic kidney disease and\u002For very high\u002Fhigh risk of cardiovascular disease, meet any one of the following:\n* A. ASCVD, including coronary heart disease, cerebral infarction, peripheral vascular disease;\n* B. Or target organ damage (albuminuria, renal impairment with eGFR ≥ 30 ml\u002Fmin\u002F1.73m2, left ventricular hypertrophy or retinopathy);\n* C. ≥ 3 major risk factors (age ≥ 65 years old, hypertension, dyslipidemia, smoking, obesity );\n* D. Diabetes duration ≥ 10 years, with any one traditional cardiovascular risk factor such as advanced age, obesity, smoking, sedentary, family history of cardiovascular disease, hypertension, abnormal lipid metabolism.\n\nExclusion Criteria:\n\n* ①Pregnant women or women planning to become pregnant;\n* ②eGFR\\\u003C30 mL\u002Fmin\u002F1.73m2 (CKD-EPI formula);\n* ③Patient cannot be followed up for 36 months (due to health condition or migration);\n* ④Unwilling or unable to sign the informed consent;\n* ⑤Type 1 diabetes;","65 Years",{"count":199,"type":20},5600,[23],"The Effects and Safety of Diabetic GUideline Algorithm Implementation in the Community (GUARD-Community) study is a 2-arm, cluster-randomized control trial to evaluate the effect and safety of guideline algorithm intervention performed by primary care physicians on cardiovascular and renal outcomes in elderly patients with high risk in community.",[203,26,204],"Type 2 Diabetes","Diabetic Kidney Disease",[206,207,208,209],"Diabetes implementation study","Diabetes guideline algorithm","Cardiovascular disease","Chronic kidney disease","2025-05-09",{"date":212,"type":32},"2025-05-14",{"date":214,"type":32},"2022-11-21",{"date":216,"type":20},"2026-11-30",{"name":218,"class":39},"Shanghai Zhongshan Hospital",13,{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":228,"sex":16,"minAge":229,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":21,"phases":232,"briefSummary":233,"conditions":234,"keywords":239,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":40},"100537528","phase-3-colchicine-in-patients-at-cardiac-risk-undergoing-major-non-cardiac-surgery-100537528","NCT06279000","Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery","Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery: Prospective, Randomized, Double-blinded, Placebo-controlled, Multi-centre Study","COLCAT","Inclusion Criteria:\n\nundergoing major non-cardiac surgery in general anaesthesia will be included. Major non-cardiac surgery is defined as:\n\n* vascular surgery (with the exception of arteriovenous shunt, vein stripping procedures and carotid endarterectomies)\n* intraperitoneal surgery\n* intrathoracic surgery\n* major orthopaedic surgery (spinal surgery or joint replacement surgery)\n* at cardiovascular risk, defined as meeting at least 1 of the following 6 criteria:\n\n  * preoperative n-terminal pro brain natriuretic peptide (NT-proBNP) ≥ 200 ng\u002Fl\n  * history of coronary artery disease\n  * history of peripheral vascular disease\n  * history of stroke\n  * undergoing major vascular surgery, with the exception of arteriovenous shunt, vein stripping procedures and carotid endarterectomies\n  * fulfilment of any 3 of the 8 following criteria:\n\n    * undergoing major surgery (intrathoracic, intraperitoneal or supra-inguinal vascular surgery)\n    * any history of congestive heart failure or history of pulmonary oedema\n    * anamnestic transient ischemic attack (TIA)\n    * diabetes under treatment with either oral antidiabetic agent or insulin\n    * age \\> 70 years\n    * history of hypertension\n    * serum creatinine \\> 175 mumol\u002Fl or calculated creatinine clearance \\< 60 ml\u002Fmin\u002F1.73m2 (cockcroft gault)\n    * history of smoking within 2 years of surgery\n    * planned surgical time ≥ 90 minutes\n    * planned postoperative hospital stay at least 1 night\n\nExclusion Criteria:\n\n* no written consent\n* inclusion in other clinical trial with direct impact on perioperative medication\n* previously reported side effects or reported intolerance from colchicine (e.g., allergic reaction or significant sensitivity to colchicine or an auxiliary substance of the IMP)\n* pregnancy or planned pregnancy and\u002For breast feeding\n* clinically significant history of drug or alcohol abuse within the last year\n* very severe frailty (≥ 8 clinical frailty scale)\n* patient with inflammatory bowel disease (e.g., Morbus Crohn or Colitis ulcerosa)\n* patient taking colchicine for other indications (e.g., familial Mediterranean fever, gout)\n* severe renal impairment (eGFR \\< 30 ml min -1 1.73 m2 -1) or end-stage renal disease with indication for haemodialysis\n* history of solid organ or bone marrow transplantation\n* systemic immune-suppression (medication (steroids \\>30mg cortisol-equivalent per day, tacrolimus etc...) or disease (e.g., myelodysplastic syndrome)\n* severe hepatic impairment with history of cirrhosis\n* chronic active hepatitis or functional disorders defined as alanine aminotransferase greater than three times the upper limit of normal\n* anticipated post-operative administration of CYP3A4 metabolized substances like cyclosporine, ketoconazole, clarithromycin, verapamil, quinidine, diltiazem or ritonavir\n* Any other condition that the investigator would consider a risk to the patient if the latter were to participate in the study.",true,"45 Years",{"count":231,"type":20},880,[115],"Perioperative myocardial injury and major adverse cardiovascular events (MACE) are common causes of morbidity and mortality in patients at increased cardiovascular risk undergoing non-cardiac surgery.\n\nHowever, research in recent years has yielded limited preventive and therapeutic measures for myocardial injury\u002FMACE. Recent studies in patients with chronic and acute coronary artery disease have shown that colchicine administration can reduce the risk of cardiovascular events.\n\nThese encouraging results in non-surgical patients ask for a similar investigation in patients undergoing major non-cardiac surgery. The aim of the proposed study is to investigate the effects of perioperative colchicine administration on the incidence of myocardial injury\u002FMACE.",[235,26,236,237,238],"Cardiovascular Diseases","Perioperative Complication","Myocardial Injury","Myocardial Injury After Noncardiac Surgery (MINS)",[240,241,242,243],"Perioperative Cardiovascular Risk","myocardial injury","major adverse cardiac events","colchicine","2025-04-19",{"date":246,"type":32},"2025-04-24",{"date":248,"type":32},"2025-04-20",{"date":250,"type":20},"2029-03-30",{"name":252,"class":39},"Cantonal Hospital of St. Gallen",{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":16,"minAge":259,"maxAge":260,"enrollmentInfo":261,"targetDuration":4,"studyType":21,"phases":263,"briefSummary":264,"conditions":265,"keywords":266,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":40},"100579610","at-home-cardiac-rehabilitation-for-adolescents-at-risk-for-heart-failure-100579610","NCT06826534","At-Home Cardiac Rehabilitation for Adolescents at Risk for Heart Failure","INCLUSION CRITERIA\n\n* Patients aged of 10-21 years at enrollment\n* Parent\u002Flegal guardian available for consent (if applicable), and patient available for assent and consent\n* History of anthracycline exposure +\u002F- radiation\n* Currently in remission, with at least 6 months off chemotherapy\n* Able to perform CPET\n* Baseline CPET with VO2 \\\u003C80% (at start of study, or CPET at CHLA after January 2020)\n* Smartphone compatible with Fitbit (own or parent\u002Flegal guardian's)\n* Ability to complete and send diary and Fitbit information on a weekly basis\n* Ability to participate in monthly virtual check-in visits\n* Baseline activity prior to intervention \\\u003C30min\u002Fday, 2x\u002Fweek\n\nEXCLUSION CRITERIA\n\n* Inability to obtain consent\u002Fassent\n* Unable to accurately perform quality of life survey independently\n* No other primary medical diagnosis (e.g., Down Syndrome, Wolff-Parkinson-White Syndrome, congenital heart disease) or history of cardiothoracic surgery\n* Contraindication to moderate activity (\\>3 METs). Examples include history of malignant arrhythmias, exercise-induced syncope, severe symptoms of HF (NYHA IV, ACC\u002FAHA Stage D)\n* Unable to perform CPET, echocardiogram, EKG, or obtain laboratory studies\n* Unable to perform mild activity for at least 0.5h\u002Fday and at least 2x\u002Fweek\n* Unable to come to hospital for study visits at 0 and 6 months\n* Unable to complete study-related surveys\n* Unable to complete and send diary and Fitbit information on a weekly basis\n* Unable to check-in monthly on virtual platform\n* On beta blockade\n* Pregnancy","0 Years","21 Years",{"count":262,"type":20},20,[23],"The goal of this clinical trial is to explore the impact that an at-home cardio-oncology rehabilitation (CORE) may have on short-term cardiovascular fitness and psychosocial wellness in pediatric cancer survivors. The main question it aims to answer are\n\n* To evaluate the efficacy of an at-home CORE model on short-term cardiovascular fitness and psychosocial wellbeing in adolescent cancer survivors.\n* To evaluate the exercise adherence rate among adolescents at risk for heart failure and assess barriers to compliance.\n* To explore which specific CORE resources are of most value to patients in creating sustainable healthy lifestyle modifications.\n* Hypothesis: Pediatric cancer survivors who implement exercise and dietary recommendations will demonstrate improvement in cardiovascular fitness and general wellness. A multidisciplinary team approach can facilitate adherence to a moderately rigorous exercise prescription, and thus enhance the health benefits of a CORE program at CHLA.\n\nParticipants will undergo cardiovascular studies and a quality-of-life survey prior to exercise intervention, and at the end of the 6-month study period.",[26,92],[267,268,269,270,271],"anthracycline exposure","cancer survivors","physical activity","pediatric oncology","cardiac rehabilitation","2025-02-12",{"date":274,"type":32},"2025-02-14",{"date":276,"type":32},"2023-10-20",{"date":278,"type":20},"2025-12-31",{"name":280,"class":39},"Children's Hospital Los Angeles",{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":285,"acronym":286,"eligibilityCriteria":287,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":21,"phases":290,"briefSummary":291,"conditions":292,"keywords":301,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":317},"100491430","phase-3-stroke-prophylaxis-with-apixaban-in-chronic-kidney-disease-stage-5-patients-with-atrial-fibrillation-100491430","NCT05679024","Stroke Prophylaxis With Apixaban in Chronic Kidney Disease Stage 5 Patients With Atrial Fibrillation","SACK","Inclusion Criteria:\n\n1. Signed Written Informed Consent\n2. 18 years of age or older\n3. Ongoing treatment with any chronic dialysis treatment OR an estimated glomerular filtration rate (eGFR)\\* \\\u003C20 ml\u002Fmin\u002F1.73 m2 at least twice 3 months apart of which at least one occasion is \\\u003C15 ml\u002Fmin\u002F1.73 m2 due to CKD during the last year (12 months).\n4. Diagnosis of chronic (i.e., repeated) paroxysmal, persistent, or permanent atrial fibrillation (AF) or atrial flutter (AFL)\n5. CHA2DS2-VASc score ≥2 or more for men ≥3 or more for women as an indication for oral anticoagulation\n6. Women of childbearing potential (WOCBP) should have a negative highly effective pregnancy test at screening and must agree to follow instructions for method(s) of contraception for the duration of treatment\n\nExclusion Criteria:\n\nParticipants may not be included in the study if any of the following criteria are met:\n\n1. AF or AFL due to reversible causes (e.g., thyrotoxicosis, pericarditis)\n2. Any degree of rheumatic mitral stenosis or moderate-to-severe non-rheumatic mitral stenosis at the time of inclusion into the study\n3. Any condition other than AF or AFL that requires chronic anticoagulation (e.g., a prosthetic mechanical heart valve, antiphospholipid syndrome).\n4. Any contraindication for anticoagulation including\n\n   1. endocarditis\n   2. documented intolerance for apixaban\n   3. liver disease with documented coagulation disorder\n   4. pregnancy or breast feeding\n5. Active bleeding or serious bleeding within 3 months, or\n\n   1. documented hemorrhagic blood dyscrasia\n   2. patients currently receiving dual antiplatelet therapy\n6. Planned for surgery\n\n   1. kidney transplantation with a living donor within 3 months\n   2. active on the kidney transplant waiting list at a kidney transplant center where apixaban use is prohibited\n   3. valvular heart disease surgery\n7. Current use of strong inhibitors of both CYP3A4 and P-glycoprotein in accordance with the summary of product characteristics (SmPC) of apixaban or regular intake of non-steroidal anti-inflammatory drugs (NSAID) or cyclooxygenase-2 (COX2) inhibitors\n8. Any condition or circumstance in which the patient should not participate in the study according to the study investigator (reason documented in the pre-screening protocol)\n\nBeing active on the kidney transplant waiting list is not an exclusion criterion if it is allowed according to the current clinical guidelines at the transplant clinic where the patient is registered. The patient must report changes in waiting list status to the investigator promptly.",{"count":289,"type":20},1400,[115],"Objective: To study the efficacy and safety of apixaban as stroke prophylaxis in patients with chronic kidney disease (CKD) stage 5 and atrial fibrillation (AF) with or without dialysis treatment. The study hypothesis is that compared to no anticoagulation, apixaban reduces the incidence of ischemic stroke without causing an unacceptable increase in fatal or intracranial bleeding events.\n\nThe secondary objectives are to evaluate the risk of all-cause mortality, cardiovascular events, and major bleeding in people with CKD stage 5 and AF treated with apixaban compared to standard of care without anticoagulation.\n\nTrial design: Pragmatic Prospective Open Label Randomized Controlled Clinical Trial, phase 3b over 12-72 months.\n\nTrial population: 1000-1400 patients at ≈50 sites in Sweden, Finland, Norway, Iceland and Poland Eligibility criteria: Adults ≥18 years with CKD stage 5 (ongoing treatment with any chronic dialysis treatment OR an estimated glomerular filtration rate (eGFR)\\* \\\u003C20 ml\u002Fmin\u002F1.73 m2 at least twice 3 months apart of which at least one occasion is \\\u003C15 ml\u002Fmin\u002F1.73 m2 due to CKD during the last 12 months) and a diagnosis of chronic, paroxysmal, persistent, or permanent AF or atrial flutter (AFL) with CHA2DS2-VASc score ≥2 for men or ≥3 or more for women as an indication for oral anticoagulation.\n\nThe exclusion criteria are AF or AFL due to reversible causes, rheumatic mitral stenosis or moderate-to-severe non-rheumatic mitral stenosis at the time of inclusion into the study, a condition other than AF or AFL that requires chronic anticoagulation, contraindications for anticoagulation, active bleeding or serious bleeding within 3 months, planned for surgery within 3 months, and current use of strong inhibitors of both CYP3A4 and P-glycoprotein.\n\nInterventions: Randomization 1:1 to treatment with apixaban 2.5 mg twice daily and standard of care, or standard of care and no anticoagulation.\n\nOutcome measures: primary efficacy (time to first ischemic stroke); primary safety (the composite of time to first intracranial bleeding or fatal bleeding); secondary efficacy (time to all-cause mortality, time to cardiovascular event or cardiovascular death); secondary safety (time to first major bleeding according to International Society on Thrombosis and Hemostasis (ISTH) criteria)",[293,294,295,296,297,26,298,299,300],"Chronic Kidney Diseases","Atrial Fibrillation","Stroke","Intracerebral Hemorrhage","Major Bleed","Death","Kidney Transplant; Complications","Thromboses, Venous",[209,302,303,304,305,306],"Hemodialysis","Peritoneal dialysis","Kidney transplantation","Atrial fibrillation","Oral anticoagulation","2024-10-02",{"date":309,"type":32},"2024-10-04",{"date":311,"type":32},"2023-02-17",{"date":313,"type":20},"2028-12-31",{"name":315,"class":316},"Region Stockholm","OTHER_GOV",34,{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":228,"sex":49,"minAge":324,"maxAge":325,"enrollmentInfo":326,"targetDuration":4,"studyType":21,"phases":328,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":40},"100562221","effect-of-dash-diet-and-progressive-muscle-relaxation-on-cardiovascular-risks-in-postmenopausal-women-100562221","NCT06600347","Effect of DASH Diet and Progressive Muscle Relaxation on Cardiovascular Risks in Postmenopausal Women","Inclusion Criteria:\n\n* The participant's ages will be ranged from 50- 60 years old.\n* Their body mass index will be ranged from 30-35 kg\u002Fm2.\n* All women are hypertensive at least one year postmenopause.\n* Their scores in perceived stress scale will be ranged from 14-40.\n\nExclusion Criteria:\n\n* Women with systolic blood pressure (SBP) \\>160 mmHg or diastolic blood pressure (DBP) \\>100mmHg.\n* Women who have other known causes of hypertension, such as renal diseases.\n* Women who are using sedatives or tranquilizer or antidepressant drugs.","50 Years","60 Years",{"count":327,"type":20},90,[23],"This study will be conducted to investigate the effect of DASH diet and Progressive muscle relaxation on cardiovascular risks in postmenopausal women.",[26],"2024-09-13",{"date":333,"type":32},"2024-09-19",{"date":335,"type":32},"2024-06-10",{"date":337,"type":20},"2024-12",{"name":339,"class":39},"Cairo University",{"id":341,"slug":342,"hasResults":11,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":346,"eligibilityCriteria":347,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":348,"targetDuration":83,"studyType":144,"phases":4,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":40},"100415933","atrial-fibrillation-in-active-cancer-patients-100415933","NCT04696081","Atrial Fibrillation in Active Cancer Patients","Multicenter International Prospective Registry to Identify Major Cardiovascular Events Associated With the Occurrence of Atrial Fibrillation in Active Cancer Patients","AFIB-CANCER","Inclusion Criteria:\n\n* adult patients\n* outpatients or hospitalized patients\n* with a confirmed cancer (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor, known intracerebral metastases, or acute leukemia) and an active cancer (defined as cancer that had been diagnosed within the past 6 months or recurrent locally advanced or metastatic cancer, for which anticancer treatment was being given at the time of enrollment or during 6 months before enrollment)\n* at least 1 episode of atrial fibrillation (new onset AF occuring after cancer diagnosis or history of paroxysmal of persistant AF prior to cancer diagnosis and an AF recurrence after cancer diagnosis)\n* in sinus rhythm at the time of cancer diagnosis\n\nExclusion Criteria:\n\n* patient with palliative cares or other conditions resulting in short term death (death expected in the month following atrial fibrillation occurrence)\n* history of long-standing persistant or permanent AF prior to cancer diagnosis",{"count":166,"type":20},"Atrial fibrillation is a common complication of both cancer and anticancer drugs but the consequences of such events remain poorly known and are not adressed in both phase III oncological trials and cardiological guidelines. The objective of this study is to create a prospective multicenter international registry of adult patients with an active cancer and experiencing atrial fibrillation to study major cardiovascular events occurrence during a 1 year follow-up.",[351,352,294,26],"Cancer","Drug Toxicity","2024-08-08",{"date":355,"type":32},"2024-08-09",{"date":357,"type":32},"2021-09-01",{"date":359,"type":20},"2026-01-01",{"name":361,"class":39},"University Hospital, Caen",{"id":363,"slug":364,"hasResults":11,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":368,"eligibilityCriteria":369,"healthyVolunteers":228,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":370,"targetDuration":372,"studyType":144,"phases":4,"briefSummary":373,"conditions":374,"keywords":380,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":40},"100485312","prospective-longitudinal-study-on-fitness-doping-in-denmark-100485312","NCT05599438","Prospective, Longitudinal Study on FItness DOping in DenmarK","Prospective, Longitudinal Study of 800 Recreational Athletes With Current and Former Use of Performance and Image Enhancing Drugs (PIED), Focusing on Androgenic Anabolic Steroids (AAS) - Rigshospitalet","FIDO-DK\u002FRH","Inclusion Criteria:\n\n\\- Male and female recreational athletes (≥18 years of age) with current or former illicit use (\\>3 months since AAS cessation) of PIEDs (e.g. AAS) for a minimum four weeks\n\nInclusion Criteria (Controls, n = 100):\n\n\\- Male (n=80) or female (n=20) recreational athletes (≥18 years of age) with NO current or former illicit use of AAS.\n\nExclusion Criteria:\n\n* Severe psychiatric or somatic diseases which makes it impossible to give informed consent or comply with the investigatory program.\n* Known pregnancy.",{"count":371,"type":20},900,"15 Years","The aim of this prospective longitudinal study is to investigate the risks associated with use of anabolic steroids in fitness circles in Denmark in order to assess the scope of therapeutic need existing as a consequence of use. The objectives are:\n\n* To assess long-term complications and outcomes related to: cardiovascular disease, diabetes, gonadal disease (women and men) and psychiatric disease using data from Danish registries including addressing central questions such as whether the following characteristics play a role for development of overt disease\n* Characterization of illicit AAS use among men and women\n* Current male reproductive health\n* Current psychological well-being, aggressive tendencies, cognitive function and quality of life\n* Current cardiovascular and metabolic status\n\nThe participants will undergo:\n\n* Semi-structured medical interview\n* Physical examinations\n* Questionnaires\n* Blood and urine sampling\n* Dual X-ray Absorptiometry\n\nWith a subset undergoing further testing, including semen analysis, gonadotropin-releasing hormone (GnRH) and human chorionic gonadotropinm (hCG) stimulation and 82Rubidium positron emission tomography and computer tomography (PET\u002FCT).\n\nRegister-based follow-up is planned every third year until the 15th year, marking the completion of the trial.\n\nThe study will include 800 participants with current or former AAS use and 100 participants (80 male; 20 female) as controls with no former or current use of AAS.",[375,376,26,377,378,379],"Anabolic Steroid Overdose","Infertility","Illicit Drug Use","Fitness","Mental Health Issue",[381,382,376,383],"Cardiovascular Disease","Metabolic syndrome","Mortality","2024-02-14",{"date":386,"type":32},"2024-02-15",{"date":388,"type":32},"2022-06-14",{"date":390,"type":20},"2040-06-01",{"name":392,"class":39},"Caroline Michaela Kistorp",{"id":394,"slug":395,"hasResults":11,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":40},"100500718","fast-track-cardiovascular-assessment-for-suspicion-of-cardiovascular-events-on-immunecheckpoint-inhibitors-100500718","NCT05799898","Fast-Track Cardiovascular Assessment for Suspicion of Cardiovascular Events on Immunecheckpoint Inhibitors","Fast-Track Cardiovascular Assessment for Suspicion of Cardiovascular Events on Immunecheckpoint Inhibitors: Prospective Cohort Study.","FAST-TRACK","Inclusion Criteria:\n\n* all patient referred to the cardio oncology unit for suspected immune related cardiovascular complication on immune checkpoint inhibitors\n\nExclusion Criteria:\n\n* none",{"count":51,"type":20},"Prospective study cohort on patients addressed for suspected cardiovascular event on immune checkpoint inchibitors.\n\nLongitudinal prospective single center cohort. Inclusion criteria: all patient willing to particiupate seen in the cardio-oncology unit at our institution for the suspicion of heart failure, atherosclerosis related event, Tako Tsubo, arrhymias, pericarditis, myocarditis on antiPD1, antiPDL1, or antiCTLA4 immune checkpoint inhibitors.\n\nDescription of patients characteristics, investigations, diagnosis after multidisciplinary meeting, outcomes.",[351,404,26,405],"Immune Checkpoint Inhibitor","Immune-related Adverse Event","2023-03-23",{"date":408,"type":32},"2023-04-05",{"date":410,"type":32},"2022-03-01",{"date":412,"type":20},"2030-01-01",{"name":414,"class":39},"Institut Mutualiste Montsouris",{"id":416,"slug":417,"hasResults":11,"nctId":418,"briefTitle":419,"officialTitle":419,"acronym":4,"eligibilityCriteria":420,"healthyVolunteers":11,"sex":16,"minAge":421,"maxAge":4,"enrollmentInfo":422,"targetDuration":4,"studyType":21,"phases":423,"briefSummary":424,"conditions":425,"keywords":429,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":444},"100470541","therapeutic-plantar-electrical-stimulation-intervention-during-hemodialysis-to-improve-balance-and-mobility-100470541","NCT05407207","Therapeutic Plantar Electrical Stimulation Intervention During Hemodialysis to Improve Balance and Mobility","Inclusion Criteria:\n\n* Male and female patients with diabetes receiving dialysis who are \\>40 years old.\n* Ambulatory (able to independently walk 20m with or without walking assistance).\n* Willing and able to provide informed consent.\n* Diabetes will be defined based on the American Diabetes Association (ADA) criteria (83).\n* Evidence of peripheral neuropathy and its severity will be determined based on a neurologic examination using criteria explained in the ADA statement.\n\nExclusion Criteria:\n\n* Have an active foot ulcer, an active infection, Charcot neuroarthropathy, or major foot amputation.\n* Patients with any clinically significant medical or psychiatric condition, or laboratory abnormality that would, in the judgment of the investigators, interfere with the ability to participate in the study.\n* Patients concurrently participating in exercise training; major hearing\u002Fvisual impairment; any patient with changes in psychotropic or sleep medications in the last 6 weeks.\n* If they were unlikely to fully comply with the follow-up protocol (e.g., travel plans).","40 Years",{"count":86,"type":20},[23],"A high prevalence of diabetes has been reported in Qatar with nearly 23% population suffering from the pandemic, thereby increasing the associated healthcare cost. Low compliance with exercise and physical activity in patients with diabetes increases foot risk complications, deteriorates health, and further increases economic costs. This is particularly true among patients with diabetes who are undergoing hemodialysis (HD) process. Exercise interventions have been shown to improve mobility and balance, reduce the incidence of falls, and improve peripheral blood flow, which is essential to reduce foot problems and peripheral arterial disease. However, uptake of exercise programs for individuals who are undergoing HD treatment has been limited. The three main factors limiting uptake and adherence among HD patients are time availability, post-dialysis fatigue, and transportation to exercise programs, which are usually offered in rehabilitation departments or cardiovascular centers but not in nephrology departments or in free-standing dialysis clinics. Many of these patients visit clinics 3 times a week to receive hemodialysis, providing an optimal opportunity for intervention. Thus the investigators are proposing an innovative intervention based on plantar electrical stimulation treatment during HD (3 times per week) to enhance balance and quality of life while reducing the risk of peripheral arterial diseases and diabetic foot ulcers, which are highly prevalent among people with diabetes and chronic kidney disease. This interdisciplinary study is based on preliminary studies, in which the investigators demonstrated that regular plantar electrical stimulation is an effective and practical therapy to enhance motor performance and plantar sensation in patients with diabetes. The scientific premise of the proposed intervention has been also supported by literature as well as three systematic reviews suggesting the effectiveness of electrical stimulation to reduce pain, improve balance, improve skin perfusion, and improve plantar sensation. In the context of this study, the investigators propose to bring an innovative technology based on an FDA-cleared bio-electric stimulation technology (BEST®) microcurrent platform, named Tennant Biomodulator® (Avazzia Inc., Dallas, TX, USA), which is a transcutaneous electrical nerve stimulator (TENS) and has been designed for symptomatic relief and management of chronic pain. However, the system was modified to provide electrical stimulation to the plantar area via two electrodes placed on the hind and forefoot area instead of the leg. The device has a 60-minute run cycle after which it automatically turns off. In the context of a previous study funded by QNRF, the investigators developed and tested 50 electrical stimulation units (which will be used in the context of the study), including 25 active systems and 25 placebo systems. The placebo systems are similar to active systems in the appearance and functioning of lights and indicators. However, they were programmed not to provide any electrical current.\n\nIn a preliminary study, the proof of concept of this revised technology was tested in the context of enhancing balance and skin perfusion in ambulatory patients with diabetes and peripheral neuropathy. In the context of this study, the investigators plan to translate this technology for routine treatment during HD sessions for patients with diabetes who are undergoing regular HD treatment. Using a double-blinded randomized-controlled model, the investigators will validate the effectiveness of this technology to enhance balance, reduce pain, and improve skin perfusion. One hundred (n=100) HD volunteers with diabetes will be recruited and randomized to either intervention (n=50) or control (CG: n=50) group for the purpose of this study. Plantar electrical stimulation will be provided during HD sessions, 3 times per week and for 12 weeks. Outcomes will be assessed at baseline, 6 weeks, and 12 weeks to examine the effectiveness of the proposed intervention to enhance balance, improve quality of life, and improve lower extremity skin perfusion among HD patients with diabetes.\n\nThis proposal is in line with Qatar National Priorities Research goals and if successful the result will open new doors to managing diabetes and kidney failure. In a setting where no therapeutic agents or interventions effectively address poor balance and loss of protective sensation among HD patients with diabetes and where affected individuals life with a heightened risk of developing a debilitating foot ulcer and quite possibly a disabling amputation, the potential impact from the plantar electrical stimulation system may offer the potential for significant clinical benefit, with very low risk, and with ease of implementation in routine care application for patients who are undergoing HD treatment.",[426,427,26,428],"Diabetes Mellitus","Hemodialysis Complication","Quality of Life",[430,431,432,433],"Preventive supplements","Treatment of diabetes related complications","Health intervention","Lifestyle intervention","2022-06-02",{"date":436,"type":32},"2022-06-07",{"date":438,"type":32},"2018-06-01",{"date":440,"type":20},"2022-11-11",{"name":442,"class":443},"Hamad Medical Corporation","INDUSTRY",2]