[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Silesian Centre for Heart Diseases\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":121},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,61,96],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":39,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100474986","phase-4-sacubitrilvalsartan-in-primary-prevention-of-the-cardiotoxicity-of-systematic-breast-cancer-treatment-mainstream-100474986",false,"NCT05465031","Sacubitril\u002FValsartan in PriMAry preventIoN of the Cardiotoxicity of Systematic breaST canceR trEAtMent (MAINSTREAM)","Sacubitril\u002FValsartan in PriMAry preventIoN of the Cardiotoxicity of Systematic breaST canceR trEAtMent","Inclusion Criteria:\n\n* Written informed consent\n* Female gender, aged 18 years and over\n* Patients with histologically confirmed breast cancer and complete assessment of tumor phenotype (Estrogen receptor - ER, Progesterone receptor - PR, Human epidermal growth factor receptor 2 - HER2, Kiel - Ki67)\n* Ability to take oral medication and willingness to adhere to the planned regimen\n* Tumor grade IA-IIIC or oligometastatic grade IV\n* Radical treatment plan including surgery\n* Plan of use of systemic treatment (preoperative, postoperative or combined) with anthracyclines and\u002For anti-HER2 drugs\n* Eastern Cooperative Oncology Group (ECOG) 0-2 general status\n* LVEF ≥ 50% as assessed by echocardiography\n* Sinus rhythm\n\nExclusion Criteria:\n\n* Prior anthracycline-based chemotherapy and\u002For thoracic radiotherapy (prior to diagnosis of the cancer being the present cause of therapy)\n* Clinically relevant HF (NYHA II-IV)\n* Myocardial infarction (MI) within the last \\\u003C 3 months\n* Symptomatic hypotension or systolic blood pressure (SBP) \\\u003C 90 mmHg\n* Significant valvular disease, symptomatic coronary artery disease (CCS\\>2), significant atrioventricular (AV) block, symptomatic sinus node dysfunction\n* Expected survival \\\u003C12 months\n* Glomerular filtration rate (GFR) \\\u003C30 ml\u002Fmin\u002F1.73 m2 (screening visit)\n* K+\\>5.5mmol\u002FL (screening visit)\n* Contraindications to angiotensin converting enzyme inhibitor (ACE-I)\u002Fangiotensin II receptor blocker (ARB) or LCZ696 if not listed among criteria\n* Active untreated liver disease\n* Pregnancy\n* Conditions\u002Fcircumstances that may lead to non-compliance with medical staff recommendations (e.g. active drug\u002Falcohol dependence, poorly controlled mental illness)","FEMALE","18 Years",{"count":19,"type":20},600,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","Breast cancer is the most commonly cancer in women in the overall global population. According to the World Cancer Research Fund International, there were more than 2.25 million new cases of breast cancer in women in 2020. Although the modern treatment strategies, based on the complex care, which consists of surgery, radiotherapy, hormone therapy, and targeted chemotherapy directed at specific cancer molecules have substantially reduced the risk of death due to breast cancer, their wide adoption results in the wider prevalence of cardiotoxicity, defined as either symptomatic heart failure, or asymptomatic contractile dysfunction. The occurrence of cardiotoxicity induced by anti-cancer therapies is estimated at 5-15%, and its development is the primary cause of therapy termination, which significantly reduces the probability of the efficacy of treatment. Several attempts have been made to determine the efficacious preventive strategy, which could diminish the risk of cancer-therapy induced cardiotoxicity. The results of the prior studies indicated a trend towards lower risk of troponin elevation, or left ventricular contractile dysfunction with the introduction of drugs interfering with the renin-angiotensin-aldosterone (RAA) axis, which constitute the primary treatment modality in heart failure with reduced ejection fraction (HFrEF). Sacubitril\u002Fvalsartan, the novel therapeutic agent, has been demonstrated to significantly improve prognosis in patients with HFrEF. Prior retrospective, small, single-center studies have shown that treatment with sacubitril\u002Fvalsartan may reduce the risk of cancer-therapy induced cardiotoxicity, or reverse contractile dysfunction caused by anti-cancer therapy. However, no large randomized data confirmed these findings.\n\nTherefore, the Sacubitril\u002FValsartan in PriMAry preventIoN of the cardiotoxicity of systematic breaST canceR trEAtMent) study, has been designed to verify, whether the preventive use of sacubitril\u002Fvalsartan administered in the doses recommended in patients with HFrEF in breast cancer patients undergoing adjuvant chemotherapy with anthracyclines or anthracyclines and HER-2 monoclonal antibodies, will reduce the incidence of cardiotoxicity defined as impaired left ventricular systolic function on transthoracic echocardiography (TTE). In the trial, a total of 480 patients with histologically confirmed breast cancer, who are eligible for chemotherapy with anthracyclines or anthracyclines and HER-2 monoclonal antibodies, will undergo 1:1 randomization to either preventive treatment with sacubitril\u002Fvalsartan or placebo. The patients will be followed for 24 months, and will have repetitive efficacy and safety examinations, including echocardiography, MRI (optionally), electrocardiography including 24-h Holter monitoring, blood tests, functional capacity tests and quality of life assessment.",[26,27,28,29,30,31,32,33,34,35,36,37,38],"Breast Cancer","Neoplasm, Breast","Breast Diseases","Antihypertensive Agents","Sacubitril\u002FValsartan","Angiotensin II Type 1 Receptor Blockers","Angiotensin Receptor Antagonists","Molecular Mechanisms of Pharmacological Action","Heart Failure","Cardiac Toxicity","Cancer, Therapy-Related","Cancer Therapy-Related Cardiac Dysfunction","Cardiotoxicity",[40,30,41,42,43,26,38,44,45,46,47],"LCZ696","Magnetic Resonance Imaging","Echocardiography","Cardio-oncology","Anthracyclines","Trastuzumab","Heart failure","Cardioprotection","RECRUITING","2025-03-11",{"date":51,"type":52},"2025-03-14","ACTUAL",{"date":54,"type":52},"2024-04-17",{"date":56,"type":20},"2029-02",{"name":58,"class":59},"Silesian Centre for Heart Diseases","OTHER",4,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":69,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":74,"conditions":75,"keywords":80,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100467624","cerebral-protection-in-transcatheter-left-atrial-appendage-occlusion-100467624","NCT05369195","Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion","Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation","LAAC-SBI","Inclusion Criteria:\n\n1. 18 Years and older\n2. Subject able to provide signed informed consent.\n3. Documented permanent, persistent, or paroxysmal atrial fibrillation\n4. CHA2DS2VASc risk of stroke ≥2\n5. At least one of the following criteria:\n\n   1. Contraindications to the use of anticoagulants,\n   2. HSBLED bleeding risk ≥3\n\nExclusion Criteria:\n\n1. Serious mental diseases, particularly: dementia syndrome of any etiology, schizophrenia,schizoaffective disorders, bipolar disorder\n2. History of ischemic stroke\n3. Chronic abuse of alcohol or any other psychoactive substances except for nicotine\n4. long-term therapy with benzodiazepines\n5. The use of antidepressants in 3 months prior inclusion.\n6. Previous infections of the central nervous system, including neuroborreliosis\n7. Parkinson's disease\n8. Huntington's chorea\n9. Creutzfeld-Jakob disease\n10. Pick's disease\n11. Significant atherosclerosis of the cephalic arteries (\\> 70% LCCA or the brachiocephalic trunk)\n12. Strictures, ectasias, dissection or aneurysms at the exit of the LCCA or the brachiocephalic trunk from the aorta and up to 3 cm above\n13. Advancement of vascular changes in DW MRI of the head, grade 3 on the Fazekas scale\n14. Presence of a thrombus or tumours of a different nature in the left atrium or its ear\n15. Presence of a thrombus in the left ventricle\n16. Left atrial appendage anatomy preventing the use of occluders to close the left atrium appendage\n17. The presence of mechanical heart valve prostheses\n18. The state after the operative closure of the defect in the atrial septum\n19. Condition after closing the defect in the interatrial septum with the use of occluders\n20. Active infective endocarditis\n21. Presence of devices and prostheses that prevent the performance of MRI (pacemakers, clips in the CNS)\n22. Status after oesophagal surgery\n23. Esophageal diverticula\n24. Esophageal varices\\> grade 3\n25. Allergic to contrast agents\n26. A contraindication to use antiplatelet drugs\n27. Diagnosis of neoplastic disease with estimated survival beyond 1 year\n28. Clininally evident hypothyroidism and hyperthyroidism\n29. Klaustrofobia\n30. Pregnancy\n31. AIDS\n32. Participation in other drug research studies\n33. The presence of circumstances or any medical condition the Investigator considers problematic for subject inclusion, or test results that may couse problems to provide reliable, acurate to interpretation results","ALL",{"count":71,"type":20},240,[73],"NA","The study aims to assess the effect of the use of neuroprotection in transcutaneous occlusion of the left atrial appendage in patients with atrial fibrillation on the risk of perioperative silent brain ischemia and associated cognitive impairment and depression.",[76,77,78,79],"Atrial Fibrillation","Silent Stroke","Cognitive Impairment","Depression",[81,82,83,84,85,86],"cerebral protection","left atrial appendage occlusion","atrial fibrillation","silent brain ischemia","cognitive impairment","depression","2023-09-26",{"date":89,"type":52},"2023-09-28",{"date":91,"type":52},"2023-05-26",{"date":93,"type":20},"2026-09",{"name":58,"class":59},6,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":69,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":106,"studyType":107,"phases":4,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},"100345729","stable-angina-management-and-treatment-100345729","NCT03781492","Stable Angina Management and Treatment","Prospective REgistry of Stable Angina manaGEment and Treatment","PRESAGE","Inclusion Criteria:\n\n* symptom based diagnosis of stable angina\n\nExclusion Criteria:\n\n* acute coronary syndrome on admission\n* ≤ 18 years old",{"count":105,"type":20},25000,"5 Years","OBSERVATIONAL","The Prospective REgistry of Stable Angina manaGEment and Treatment (PRESAGE) is an observational study on an all-comer stable angina population hospitalised in a highly specialized cardiovascular centre with cardiac surgery facilities. The aim of the study is to assess the clinical characteristics, treatment modalities, early and long-term outcomes in this population.",[110,111],"Stable Angina","Coronary Artery Disease","2020-05-21",{"date":114,"type":52},"2020-05-26",{"date":116,"type":52},"2006-01-01",{"date":118,"type":20},"2026-12-31",{"name":58,"class":59},1,""]