[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567356":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":44,"locations":53,"responsibleParty":67,"collaborators":70,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":12,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":101,"overallStatus":105,"whyStopped":12,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"IRCCS Ospedale San Raffaele","OTHER",[8,13,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Care Group","NO_INTERVENTION","Participants receive standard follow-up care with Guideline-Directed Medical Therapy (GDMT) adjustments as per the physician's usual practice.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Rapid Up-Titration GDMT Group with Point-of-Care (PoC) Monitoring","EXPERIMENTAL","Patients will undergo rapid up-titration of GDMT. Their progress will be closely monitored using Point-of-Care (PoC) technology from Roche Diagnostics for NT-proBNP measurements.",[18,19],"Other: Rapid Uptitration of Guideline-Directed Medical Therapy","Diagnostic Test: Elecsys® NT-proBNP - Roche Diagnostics",{"label":21,"type":15,"description":22,"interventionNames":23},"Rapid Up-Titration GDMT Group with Hospital Monitoring","Patients will undergo rapid up-titration of GDMT. Their progress will be closely monitored using hospital-based blood tests (Roche Elecsys central laboratory platform).",[24],"Other: Rapid Up-Titration GDMT Group with Hospital Monitoring",[26,30,37],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":12},"Rapid Uptitration of Guideline-Directed Medical Therapy","Rapid up-titration of GDMT guided by protocol-specific guideline.",[14],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DIAGNOSTIC_TEST","Elecsys® NT-proBNP - Roche Diagnostics","An assay provided by Roche (Elecsys® NT-proBNP - Roche Diagnostics) will be used to assess NT-proBNP levels in the Rapid Up-Titration GDMT Group with Point-of-Care (PoC) Monitoring, with the purpose of evaluating any differences in marker dosage between the indicated method and the monitoring by the hospital laboratory analysis.",[14],[36],"Point-of-Care (PoC) Monitoring",{"type":6,"name":21,"description":38,"armGroupLabels":39,"otherNames":12},"Rapid Up-Titration GDMT Group guided by protocol-specific guideline and hospital monitoring.",[21],[41],{"name":42,"affiliation":5,"role":43},"Francesco Maisano, Head of Cardiac Surgery","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":12,"email":49},"Francesco Maisano, PI","CONTACT","+39 3478497733","maisano.francesco@hsr.it",{"name":51,"role":47,"phone":48,"phoneExt":12,"email":52},"Cosmo Godino, Co-PI","godino.cosmo@hsr.it",[54],{"facility":5,"status":12,"city":55,"state":12,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Milan","20132","Italy","IT",{"type":60,"coordinates":61},"Point",[62,63],9.18951,45.46427,{"lat":63,"lon":62},[66],{"name":51,"role":47,"phone":48,"phoneExt":12,"email":52},{"type":43,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Cosmo Godino","Doctor (Co-PI)",[71],{"name":72,"class":73},"Hoffmann-La Roche","INDUSTRY","100567356","optimization-of-heart-failure-hf-medical-therapy-after-transcatheter-valve-intervention-tvi-in-patients-with-heart-failure-with-reduced-ejection-fraction-hfref-100567356",false,"NCT06667128","Optimization of Heart Failure (HF) Medical Therapy After Transcatheter Valve Intervention (TVI) in Patients With Heart Failure With Reduced Ejection Fraction (HFrEF)","OPTIMAV","Inclusion Criteria:\n\n* Hospital admission for severe symptomatic valve disease (aortic stenosis, mitral regurgitation, or tricuspid regurgitation) effectively treated with transcatheter valve intervention (TVI) during hospitalization.\n* Chronic heart failure with reduced ejection fraction (HFrEF)\n* At the time of randomization (1-2 days prior to discharge):\n\n  1. NT-proBNP \\> 900 pg\u002FmL.\n  2. Systolic blood pressure ≥ 100 mmHg.\n  3. Heart rate ≥ 60 bpm.\n  4. Serum potassium ≤ 5.0 mEq\u002FL (mmol\u002FL).\n* At the time of hospital admission treated with ≤ ½ of the of optimal dose of ACEi\u002FARB\u002FARNi, ≤ ½ of the of optimal dose of beta-blocker, and ≤ ½ of the of optimal dose of MRA, either with or without SGLT2ic.\n* Residency in the Lombardy region.\n* Written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 or \\> 85 years.\n* Clearly documented intolerance to ACEi\u002FARB\u002FARNI, or beta-blockers, or MRA, or SGLT2i.\n* Residual severe valve disease of the valve treated with TVI (i.e. severe aortic stenosis or severe paravalvular leak after TAVR, severe mitral stenosis or severe residual mitral regurgitation after mitral valve intervention, or severe tricuspid stenosis or severe residual tricuspid regurgitation after tricuspid valve intervention).\n* Presence at the time of randomization (1-2 days prior to discharge) of any severe valve disease.\n* Hemodynamically significant obstructive lesion of the left ventricular outflow tract.\n* Significant pulmonary disease contributing substantially to the patients' dyspnea such as FEV1\\\u003C 1 liter or need for chronic systemic or non-systemic steroid therapy, or any kind of primary right HF such as primary pulmonary hypertension or recurrent pulmonary embolism.\n* Myocardial infarction, unstable angina or cardiac surgery within 3 months, or cardiac resynchronization therapy device implantation within 3 months, or percutaneous transluminal coronary intervention, within 1 month prior to screening.\n* Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy.\n* History of heart transplant or on a transplant list or using or planned to be implanted with a ventricular assist device.\n* Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior to screening that is untreated.\n* Active infection at any time during hospitalization requiring intravenous antibiotics.\n* Stroke or TIA within 3 months prior to screening.\n* Primary liver disease considered to be life threatening.\n* Renal disease or eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m2 (as estimated by the simplified MDRD formula) at screening or history of dialysis.\n* Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy \\\u003C12 months.\n* Prior (defined as less than 30 days from screening) or current enrollment in a CHF trial or participation in an investigational drug or device study within the 30 days prior to screening.\n* Discharge to a rehabilitation of long-term care facility.\n* Inability to comply with all study requirements, due to major co-morbidities, social or financial issues, or a history of noncompliance with medical regimens, that might compromise the patient's ability to understand and\u002For comply with the protocol instructions or follow-up procedures\n* Pregnant or nursing (lactating) women.","ALL","18 Years","85 Years",{"count":85,"type":86},160,"ESTIMATED","INTERVENTIONAL",[89],"NA","This trial is a single-center, open-label, randomized study designed to assess the impact of a rapid up-titration of Guideline-Directed Medical Therapy (GDMT) on heart failure with reduced ejection fraction (HFrEF) patients following transcatheter valve interventions. The study focuses on the efficacy of intensive treatment in decreasing NT-proBNP levels and improving patient outcomes, including survival rates and quality of life over a six-month period. Patients are closely monitored using both Point-of-Care technology and hospital-based assessments, with the goal of enhancing GDMT adjustments. This approach is compared to standard care to determine its potential benefits in the management of HFrEF post-valve intervention.",[92,93,94,95,96,97,98,99,100],"Heart Failure","Valvulopathy","Aortic Stenosis","Aortic Regurgitation Disease","Mitral Regurgitation","Tricuspid Regurgitation","Brain Natriuretic Peptide","Mitraclip","TAVI(Transcatheter Aortic Valve Implantation)",[92,94,102,96,97,99,103,104],"Aortic Regurgitation","Triclip","TAVI","NOT_YET_RECRUITING","2024-10-31",{"date":108,"type":109},"2024-11-04","ACTUAL",{"date":111,"type":86},"2025-02-01",{"date":113,"type":86},"2026-02-01",{"name":5,"class":6},1]