eOSS-ATTR Study (eHealth Based Operative Support System in ATTR-CM)
NCT Number: NCT06499064
Acronym: eOSS-ATTR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure|Amyloid Cardiomyopathy|ATTR Amyloidosis Wild Type|ATTR Gene Mutation
Interventions: PROCEDURE: mHealth
Sponsor: Hospital Universitari de Bellvitge
Collaborators: Institut d'Investigació Biomèdica de Bellvitge
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09-15
Completion Date: 2026-03-15

Summary:
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.

Primary Outcome Measures: Improvement of self-care using a validated scale (European Heart Failure Self-Care Behavior Scale)., changes in patient-reported outcomes (PROMs) such as self-care European Heart Failure Self-Care Behaviour Scale) between patients followed and monitored using the mHealth-based digital tool (mHealth) and those in standard follow-up (usual care \[UC\])., Six months after inclusion of the patient|Improvement of quality of life using a validated questionnaire (EUROQOL - 5D)., Comparison of both strategies at the end of follow-up., Six months after inclusion of the patient
Secondary Outcome Measures: Occurrence of new clinical events (readmission [all-cause, HF, CV and non-CV] rate and total number; worsening HF events; urgent HF visits; all-cause, CV and non-CV death)., Comparison of both strategies at the end of follow-up., Six months after inclusion of the patient|Incidence of implantation of devices (pacemakers, cardiac resynchronization therapy [CRT] or implantable cardioverter defibrillator [ICD]), Comparison of both strategies at the end of follow-up., Six months after inclusion of the patient|Change of NYHA functional class, Comparison of both strategies at the end of follow-up., Six months after inclusion of the patient|Change of 6-minutes walking test [6MWT] distance., Comparison of both strategies at the end of follow-up., Six months after inclusion of the patient|Evolution of ATTR-CM stages, Comparison of both strategies at the end of follow-up., Six months after inclusion of the patient|Changes in prognostic biomarkers: atrial natriuretic peptide levels (brain natriuretic peptide [BNP] and/or N-terminal-pro-brain natriuretic peptide [NT-proBNP]) and troponin levels (troponin T [TnT] and/or troponin I [TnI])., Comparison of both strategies at the end of follow-up., Six months after inclusion of the patient|Improvement of patient reported experience measures such as IEXPAC questionnaire (Instrumento de Evaluación de la eXperiencia del PAciente Crónico) or Evaluation Tool of the Chronic Patient Experience and patient satisfaction (Net Promoter Score [NPS])., Comparison of both strategies at the end of follow-up., Six months after inclusion of the patient