[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":108},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,82],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100637749","an-observational-study-to-evaluate-treatment-patterns-in-high-very-high-and-extreme-cardiovascular-risk-patients-with-hypercholesterolemia-including-familial-hypercholesterolemia-100637749",false,"NCT07606118","An Observational Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia","An Observational Longitudinal Multicenter Prospective Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia, Over a 1-Year Follow- Up","TRAP-HC","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of hypercholesterolemia (including clinical or genetic FH) OR high\u002Fvery high\u002Fextreme CV risk\n* Baseline visit within enrollment window (six months)\n\nExclusion Criteria:\n\n* Significant secondary dyslipidemia (e.g. hypertriglyceridemia)\n* Treatment changes due to non-hypercholesterolemia conditions","ALL","18 Years",{"count":20,"type":21},2500,"ESTIMATED","OBSERVATIONAL","TRAP-HC is a multicenter, observational, longitudinal, prospective study designed to evaluate real-world treatment patterns and lipid-lowering therapy (LLT) management in patients with hypercholesterolemia, including familial hypercholesterolemia (FH), who are at high, very high, or extreme cardiovascular risk. Approximately 2,500 adult patients will be enrolled across up to 15 Italian LIPIGEN network centers and followed for 12 months as part of routine clinical practice.\n\nThe study aims to assess LDL-C goal attainment according to current European guidelines, evaluate changes in lipid profiles over time, and investigate treatment adherence, persistence, and therapeutic modifications in response to clinical needs. Data collected during routine visits will include lipid parameters, cardiovascular history, concomitant therapies, safety outcomes, and patient-reported adherence measures.\n\nBy providing real-world evidence on the management of hypercholesterolemia in high-risk populations, the study seeks to identify current gaps between guideline recommendations and clinical practice and to support optimization of cardiovascular risk reduction strategies.",[25,26,27],"Hypercholesterolaemia","Familial Hypercholesterolaemia","CVD Risk",[29,30,31,32,33,34,35,36,37],"LDL Cholesterol","Lipid-Lowering Therapy","Cardiovascular risk","LDL-C goal attainment","Real-world evidence","Lipid Profil","Adherence to Lipid-Lowering Therapies","Changes in Treatment Regimens","Patient Attitudes and Clinical Practices","NOT_YET_RECRUITING","2026-05-20",{"date":41,"type":42},"2026-05-26","ACTUAL",{"date":44,"type":21},"2026-06-30",{"date":46,"type":21},"2027-12-31",{"name":48,"class":49},"Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)","OTHER",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100627362","assessing-the-impact-of-intensification-of-lipid-lowering-therapy-with-guidelines-based-evinacumab-administration-on-coronary-plaque-volumes-measured-by-coronary-computed-tomography-angiography-ccta-in-patients-with-homozygous-familial-hypercholesterolemia-hofh-100627362","NCT07447648","Assessing the Impact of Intensification of Lipid Lowering Therapy With Guidelines-based Evinacumab Administration on Coronary Plaque Volumes Measured by Coronary Computed Tomography Angiography (CCTA) in Patients With Homozygous Familial Hypercholesterolemia (HoFH)","Assessing the Impact of Intensification of Lipid Lowering Therapy With Guidelines-based Evinacumab Administration on Coronary Plaque Volumes Measured by Coronary Computed Tomography Angiography (CCTA) in Patients With Homozygous Familial Hypercholesterolemia (HoFH): A Real World, Prospective and Retrospective, Observational Study","EVOLVE-HoFH","Inclusion Criteria (intensified treatment group - Evinacumab):\n\n1. Willing and able to provide written informed consent form\u002Fassent form for the use of retrospective and prospective data.\n2. Male or female patients aged ≥12 years old at time of enrolment (exception for Italy and France ≥18 years).\n3. Clinical or genetic diagnosis of Homozygous Familial Hypercholesterolemia (HoFH) according to the consensus statement by Cuchel et al, 2023; EHJ (14).\n4. Patients who initiated Evinacumab (at the approved dosage and administration) within 24 months before enrolment as add-on to lipid-lowering treatment (with statins, ezetimibe, PCSK9i and\u002For other agents or treatment) at stable dose for at least 30 days before Evinacumab initiation, as per routine clinical care and no change in dosing is anticipated.\n5. Availability of a baseline CCTA performed at least 6 months prior or 1 month after Evinacumab initiation and a follow-up CCTA performed 18-24 months after Evinacumab initiation.\n6. LDL-cholesterol ≥ 140 mg\u002Fdl (3.5 mmol\u002FL) despite lipid-lowering treatment.\n\nInclusion criteria (conventional treatment group - No Evinacumab)\n\n1. Willing and able to provide written informed consent form\u002Fassent form for the use of retrospective and prospective data.\n2. Male or female patients aged ≥12 years old at time of enrolment (exception for Italy and France ≥18 years).\n3. Clinical or genetic diagnosis of Homozygous Familial Hypercholesterolemia (HoFH) according to the consensus statement by Cuchel et al, 2023; EHJ (14).\n4. Patients with HoFH on standard lipid-lowering therapy (statins, ezetimibe, PCSK9i and\u002For other agents or treatment) at stable dose for at least 30 days before a baseline CCTA and with a follow-up CCTA after 18-24 months from the baseline one.\n\n   * Required lipid lowering therapies: statin, ezetimibe and PCSK9 directed therapy (unless discontinuation due to \\\u003C15% LDL-cholesterol reduction).\n   * Optional additional lipid-lowering therapies:\n   * Lipoprotein apheresis, at stable intervals for at least 3 months.\n   * Lomitapide, at stable dose for at least 3 months.\n5. LDL-cholesterol ≥ 140 mg\u002Fdl (3.5 mmol\u002FL) despite lipid-lowering treatment.\n\nExclusion criteria (intensified treatment group - Evinacumab)\n\n1. Patients participating in a clinical trial with an investigational drug within the last 6 months.\n2. Patients treated outside of Evinacumab approved indication.\n3. Inability to access adequate retrospective clinical data from medical records.\n4. Inability or unwillingness to provide informed consent\u002Fassent or refusal to participate.\n5. Previous multi-vessel coronary artery bypass grafting (CABG). Patients with single-vessel CABG are not excluded.\n6. Pregnancy at the time of the LLT administration.\n7. Moderate to severe renal impairment, or end-stage renal disease (ESRD) undergoing kidney transplantation or chronic renal replacement therapy.\n\nExclusion criteria (conventional treatment group - No Evinacumab)\n\n1. Participation in any interventional clinical trial involving investigational drugs within the last 6 months.\n2. Inability to access adequate retrospective clinical data from medical records.\n3. Inability or unwillingness to provide informed consent\u002Fassent or refusal to participate.\n4. Previous multi-vessel coronary artery bypass grafting (CABG). Patients with single-vessel CABG are not excluded.\n5. Moderate to severe renal impairment, or end-stage renal disease (ESRD) undergoing kidney transplantation or chronic renal replacement therapy.\n6. Pregnancy at the time of the LLT administration.","12 Years",{"count":60,"type":21},52,"This observational, multicenter, retrospective and prospective study aims to evaluate the impact of intensified lipid-lowering therapy including Evinacumab on coronary atherosclerotic plaque burden in patients with Homozygous Familial Hypercholesterolemia (HoFH).\n\nHoFH is a rare genetic disorder characterized by extremely elevated low-density lipoprotein cholesterol (LDL-C) levels from early life and a markedly increased risk of premature atherosclerotic cardiovascular disease. Despite combination lipid-lowering therapy, many patients do not achieve recommended LDL-C targets and remain at high cardiovascular risk.\n\nEvinacumab, a monoclonal antibody targeting angiopoietin-like protein 3 (ANGPTL3), has demonstrated significant LDL-C reduction in clinical trials. However, real-world evidence on its impact on coronary plaque progression is limited.\n\nThe study will compare HoFH patients receiving intensified lipid-lowering therapy including Evinacumab with patients receiving conventional lipid-lowering therapy without Evinacumab. Coronary plaque burden and phenotype will be assessed using coronary computed tomography angiography (CCTA) performed as part of routine clinical practice.\n\nApproximately 52 patients will be enrolled across European centers. The primary objective is to evaluate changes in non-calcified coronary plaque volume between baseline and 18-24 months' follow-up. Secondary objectives include evaluation of total plaque burden, high-risk plaque characteristics, and LDL-C reduction. Exploratory analyses will assess patient-reported outcomes, pericoronary adipose tissue characteristics, and supravalvular atherosclerosis.\n\nAll data are collected from routine clinical care. No additional procedures are mandated by the protocol. This study aims to generate real-world imaging evidence on the effect of intensified lipid-lowering therapy including Evinacumab on coronary atherosclerosis in HoFH.",[63,64],"Homozygous Familial Hypercholesterolemia (HoFH)","Coronary Computed Tomography Angiography",[66,67,68,29,30,69,70,71,64],"Evinacumab","Homozygous Familial Hypercholesterolemia","Cardiovascular Disease","Lipid Metabolism Disorders","Atherosclerosis","Rare Genetic Disorders","RECRUITING","2026-05-12",{"date":75,"type":42},"2026-05-14",{"date":77,"type":42},"2026-04-30",{"date":79,"type":21},"2029-02",{"name":48,"class":49},13,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":89,"targetDuration":91,"studyType":22,"phases":4,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100543945","lipid-transport-disorder-italian-genetic-record-lipigen-100543945","NCT06362473","Lipid Transport Disorder Italian Genetic Record (LIPIGEN)","LIPIGEN","Inclusion Criteria:\n\n* Molecular or clinical diagnosis of genetic dyslipidemia\n* Informed consent signed\n\nExclusion Criteria:\n\n* None",{"count":90,"type":21},10000,"10 Years","LIPIGEN is an observational study involving Italian physicians and researchers in the field of diseases related to blood lipid levels. This study aims to improve the diagnosis and treatment of people with familial dyslipidaemias, including very common conditions such as familial hypercholesterolaemia (FH) and less common ones such as familial chylomicronidaemic syndrome (FCS).\n\nWhat does the study do?\n\nIt collects information on Italian patients with Familial Hypercholesterolaemia (FH), following them in their normal clinical examination without adding extra procedures.\n\nIt uses the data collected to further our understanding of diseases such as familial hypercholesterolaemia, examining how it is diagnosed clinically and by genetic testing, and evaluating the effectiveness of different treatments.\n\nIt seeks to identify the genetic mutations that cause familial hypercholesterolaemia and other dyslipidaemias, helping to choose the most effective treatments.\n\nIt evaluates the impact of long-term treatments and patient adherence to medication, as well as monitoring the incidence of cardiovascular events and other important outcomes.\n\nWho can participate?\n\nThe study is aimed at people of all ages, from children to adults, with familial hypercholesterolaemia or other genetic dyslipidaemia.\n\nMore than 50 centres throughout Italy are involved, making the study accessible to many.\n\nWhat does participation entail?\n\nParticipants will continue with their normal clinical practice.\n\nData such as family history, personal clinical findings and genetic information will be collected, without additional procedures.\n\nFor some, further evaluations, such as ultrasounds, may be required to better study their condition.\n\nThe LIPIGEN study not only helps to better understand diseases related to high cholesterol but also aims to improve patients\\' lives through more precise diagnosis and personalised treatments.",[94,95],"Familial Hypercholesterolemia","Genetic Disorder",[87,97,98],"Familial Hypercholesterelomia","Genetic Dyslipidemia","2024-04-08",{"date":101,"type":42},"2024-04-12",{"date":103,"type":42},"2015-08-04",{"date":105,"type":21},"2026-09-30",{"name":48,"class":49},1,""]