[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hyperhomocysteinemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hyperhomocysteinemia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"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":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100629868","homocysteine-and-early-diastolic-dysfunction-in-newly-diagnosed-hypertension-100629868",false,"NCT07480265","Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension","Relationship Between Elevated Homocysteine Levels and Early Diastolic Dysfunction in Newly Diagnosed Hypertensive Patients","HHT-EDD","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Newly diagnosed essential hypertension within the previous 6 months\n* Ability and willingness to provide informed consent\n* Availability for clinical evaluation, laboratory testing, ambulatory blood pressure monitoring, electrocardiography, and transthoracic echocardiography\n\nExclusion Criteria:\n\n* Resistant hypertension\n* Secondary hypertension\n* Acute coronary syndrome within the previous 6 months\n* Major surgery within the previous 6 months\n* Known heart failure\n* Pulmonary hypertension\n* Congenital heart disease\n* Atrial fibrillation or atrial flutter\n* Moderate or severe valvular heart disease\n* Chronic kidney disease\n* Anemia\n* Current folate, vitamin B12, or vitamin B6 supplementation or treatment\n* Inadequate echocardiographic image quality for strain analysis\n* Known systemic conditions that may significantly affect plasma homocysteine levels","ALL","18 Years",{"count":20,"type":21},500,"ESTIMATED","2 Years","OBSERVATIONAL","This prospective single-center observational study aims to evaluate the relationship between elevated plasma homocysteine levels and early echocardiographic abnormalities in patients with newly diagnosed essential hypertension. Adult patients diagnosed with essential hypertension within the previous 6 months will undergo clinical assessment, ambulatory blood pressure monitoring, electrocardiography, laboratory testing, and comprehensive transthoracic echocardiography including diastolic function assessment and strain analysis when image quality is adequate. Participants will be classified according to plasma homocysteine level using, and patients with elevated and normal homocysteine levels will be compared with respect to diastolic dysfunction and left ventricular and left atrial global longitudinal strain parameters. Clinical, laboratory, and echocardiographic data will also be used to develop a machine-learning based model for prediction of H-type hypertension.",[26,27,28],"Hypertension (HTN)","Hyperhomocysteinemia","Diastolic Dysfunction",[30,31,32,33,34,35,36],"H-type hypertension","Homocysteine","Echocardiography","Diastolic dysfunction","Left ventricular global longitudinal strain","Left atrial global longitudinal strain","Machine learning","RECRUITING","2026-03-20",{"date":40,"type":41},"2026-03-24","ACTUAL",{"date":43,"type":41},"2025-06-02",{"date":45,"type":21},"2028-03",{"name":47,"class":48},"Necmettin Erbakan University","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":66,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":49},"100536418","evaluation-of-a-genetically-determined-personalized-approach-in-prescribing-biologically-active-substances-in-patients-with-elevated-blood-homocysteine-levels-100536418","NCT06264570","Evaluation of a Genetically Determined Personalized Approach in Prescribing Biologically Active Substances in Patients With Elevated Blood Homocysteine Levels.","Evaluation of a Genetically Determined Personalized Approach in Prescribing Biologically Active Substances in Patients With Elevated Blood Homocysteine Levels, Prospective,Double-blind Randomised Trial.","PERBIO-HC","Inclusion Criteria:\n\n* Increased homocysteine level above 15 µmol\u002Fl;\n* Increased LDL level \\>=1.4 mmol\u002Fl.;\n* Absence of taking medications or any other products that may affect homocysteine levels in the blood for at least 1 month before enrollment in the study;\n\nExclusion Criteria:\n\n* Individual intolerance to the components of the substance;\n* Pregnancy or breastfeeding;\n* Severe concomitant disease requiring constant monitoring (estimated survival less than 1 year);\n* Taking dietary supplements or medications containing one of the components: dietary supplements for at least 3 months before inclusion in the study.","80 Years",{"count":60,"type":21},111,"INTERVENTIONAL",[63],"NA","The clinical trial assesses the effectiveness and safety of a genetically-determined personalized approach to prescribing bioactive substances in patients with elevated blood homocysteine levels. Hyperhomocysteinemia (HHcy) is a risk factor for cardiovascular diseases (CVD), potentially exacerbating the effects of arterial hypertension and high cholesterol levels, increasing the risks of heart disease, stroke, and venous thrombosis. The trial aims to reduce plasma homocysteine levels to normal values (\\\u003C15 µmol\u002FL) through a pilot, single-center, prospective, double-blind, placebo-controlled study. The study will involve a 6-month observation period with visits at 1, 3, and 6 months, assessing the efficacy of two composite bioactive substances not considered medicinal drugs. The primary endpoint is the reduction of homocysteine levels in patients with elevated levels, while secondary endpoints include lowering very low-density lipoprotein levels, absence of anxiety and depression (using the Spielberg Anxiety Scale), and the occurrence of major cardiovascular events. The sample size is planned for 111 patients across three groups, with a 1:1:2 distribution, considering a 40% reduction in homocysteine levels in the treated group and 5% in the control group, aiming for an 80% power and a 0.05 alpha. Inclusion criteria include adults aged 18-80 with elevated homocysteine (\\>15 µmol\u002FL) and LDL cholesterol levels (≥1.4 mmol\u002FL), without taking any substances that could influence homocysteine levels for at least one month prior. The trial will also conduct an interim analysis after enrolling 55 patients, using statistical analysis to evaluate the results.",[27],[27,67,68,69,70],"Cardiovascular diseases","Bioactive substances","Genetically-determined approach","Nutrigenomics","2025-06-06",{"date":73,"type":41},"2025-06-08",{"date":75,"type":41},"2023-10-23",{"date":77,"type":21},"2026-10-30",{"name":79,"class":48},"S.LAB (SOLOWAYS)"]