[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554436":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":18,"responsibleParty":36,"collaborators":39,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":51,"maxAge":18,"enrollmentInfo":52,"targetDuration":18,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":66,"whyStopped":18,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":18},{"fullName":5,"class":6},"Hospital Universitari de Bellvitge","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"mHealth","EXPERIMENTAL","Structured follow-up in the basis of using mHealth-based solution. mHealth will include daily signs and symptoms telemonitoring and structured follow-up by the means of video or audio-conference.",[13],"Procedure: mHealth",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual care","NO_INTERVENTION","Patients with usual care follow-up in a heart failure due to ATTR-CM program.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"PROCEDURE","Follow-up and treatment of patients in the mHealth arm will be based on a comprehensive solution for the care and monitoring of chronic patients, modelled and tested in chronic HF patients. This is the PIRENe platform, previously described and evaluated in HF patients. It is a digital solution, external to the centre's information systems (external platform). However, it has some special features in its design in terms of remote monitoring, educational tools, among others, expressly conceived and designed for patients with ATTR-CM. This platform allows the provision of multichannel service and monitoring of patients through:\n\n1. Patient monitoring of: Biometric data and symptom report.\n2. Generation and management of warning alarms notified to the professionals assigned to each patient in case one of the following situations occurs.\n3. Follow-up via videoconference.",[9],[25],{"name":26,"affiliation":5,"role":27},"Sergi Yun Viladomat, MD","PRINCIPAL_INVESTIGATOR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":18,"email":32},"CONTACT","+34 93 260 7078","sergi.yun@bellvitgehospital.cat",{"name":34,"role":30,"phone":31,"phoneExt":18,"email":35},"Cristina Enjuanes Grau, PhD","cenjuanes@bellvitgehospital.cat",{"type":27,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Sergi Yun","Internal Medicine Specialist. MD. Principal investigator",[40],{"name":41,"class":6},"Institut d'Investigació Biomèdica de Bellvitge","100554436","eoss-attr-study-ehealth-based-operative-support-system-in-attr-cm-100554436",false,"NCT06499064","EOSS-ATTR Study (eHealth Based Operative Support System in ATTR-CM)","Information and Communications Technology (ICT)-based Modeling of Transthyretin-associated Amyloidosis Cardiomyopathies (ATTR-CM) Care: EOSS-ATTR Study (eHealth Based Operative Support System in ATTR-CM)","eOSS-ATTR","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* HF diagnosis according to European Society of Cardiology (ESC)\n* Patients with a HF decompensation in the last 12 months\n* Confirmed diagnosis of ATTR-CM (ATTRv or ATTRwt)\n* Written informed consent\n\nExclusion Criteria:\n\n* Age\\\u003C18 years old\n* Participation in another clinical trial\n* Moderate or severe cognitive impairment without a competent caregiver\n* Lack of social support\n* Institutionalized patients\n* Life expectancy less than 1 year (excluding HF)\n* Institutional-based or end-of-life care\n* Serious psychiatric illness\n* Planned cardiac surgery\n* Planned heart transplantation or left ventricular assist device (LVAD) implant\n* Patients in haemodialysis program\n* The patient is unable or unwilling to give the informed consent to participate\n* The patient is considered an unsuitable candidate for this study according to the decision of the local investigator\n* Unstable patients with signs of fluid overload or low cardiac output","ALL","18 Years",{"count":53,"type":54},50,"ESTIMATED","INTERVENTIONAL",[57],"NA","Unicenter, proof-of-concept, prospective, randomised, controlled, open-label and blinded end-point adjudication trial to assess the effect on patient-reported outcomes measures (PROMs), patient-reported experience measures (PREMs) and clinical events of a mHealth-based comprehensive management program for patients with chronic heart failure (HF) due to transthyretin-associated amyloidosis (ATTR)-cardiomyopathy (CM) by means of remote daily telemonitoring of signs and symptoms and remote structured follow-up using videoconference.",[60,61,62,63],"Heart Failure","Amyloid Cardiomyopathy","ATTR Amyloidosis Wild Type","ATTR Gene Mutation",[65],"eHealth; mHealth; telemonitoring; ATTR, heart failure","NOT_YET_RECRUITING","2024-10-21",{"date":69,"type":70},"2024-10-23","ACTUAL",{"date":72,"type":54},"2024-12-01",{"date":74,"type":54},"2026-03-15",{"name":5,"class":6}]