Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data

The goal of this study is to create a digital platform for managing patients with chronic heart failure, those with long-term ventricular assistance, or heart transplant recipients. This platform aims to help doctors make clinical decisions and change treatments based on continuous monitoring and the collection of medical, clinical, physiological, behavioral, psychosocial, and real-world data from these patients. The ultimate goal is to reduce mortality and hospitalization rates for this group of patients while improving their quality of life, safety, and well-being. To do this, participants will be divided into two groups: * Intervention Group: The data collected by the platform will be available to their treating doctors. * Control Group: Doctors will not have access to the data. All participating patients will receive a set of devices and sensors to collect data such as vital signs, physical activity, sleep quality, psychological and nutritional status, and environmental data. All this information will be gathered through a mobile app designed for the study. The follow-up will last for 18 months, during which there will be 4 in-person medical visits (spaced 4 months apart). Participation in the study won't affect patients' scheduled medical visits related to their illness or their usual treatment.

NCT Number	NCT07008729
Lead Sponsor	Puerta de Hierro University Hospital Collaborators: Hannover Medical School, Attikon Hospital, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Onassis Cardiac Surgery Centre, Hospital Universitario Ramon y Cajal
Conditions	Chronic Heart Failure, Heart Transplant Recipient, Left Ventricular Assist Device
Enrollment	390 participants
Start Date	2024-04-24
Primary Completion	2026-08-31 (estimated)
Study Completion	2026-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-04