NCT07008729

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 390 (actual)
• Sponsor: Puerta de Hierro University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Specifically, the devices that will be given to the patients and their required use will be as follows: A Smartphone: This will have the app with the platform designed for the study. The patient must interact with it daily to enter data. A Blood Pressure Monitor: The patient will need to take their blood pressure every day and send it via Bluetooth to the mobile platform (the connection setup will be done by the study team before giving it to the patients). An Oxygen Saturation Monitor: The patient will need to check their oxygen levels daily and send the data via Bluetooth to the mobile platform (the connection setup will be done by the study team before giving it to the patients). A Scale: The patient will need to weigh themselves daily and transmit the data via Bluetooth to the mobile platform (the connection setup will be done by the study team before giving it to the patients). A Smartwatch: The patient must send data on their physical activity and sleep daily via Bluetooth to the mobile platform (the connection setup will be done by the study team before giving it to the patients). Home Humidity and Temperature Sensors and a Home Gateway Device (Raspberry Pi): The patient will need to connect this last device to their home internet network. The connection setup will be done by the study team before giving it to the patients. There are other data and information that the patient must manually enter into the app, such as daily body temperature, symptoms they experience (like increased fatigue or shortness of breath), or data on the functioning of the long-term ventricular assistance (controller parameters or alarm presence). Additionally, the app will show the patient's current medication, which they need to confirm they have taken correctly. The scheduled visits during the study will take place at the Baseline and every four months. These visits will include an in-person medical visit, an electrocardiogram, a blood test, and a 6-minute walk test. Also, at each visit, a series of questionnaires will be given to assess the patient's cognitive, nutritional, and psychological state, as well as their quality of life and that of their primary caregivers. Some visits will also include more specific cardiac tests, like an echocardiogram or a cardiopulmonary exercise test. If during the study follow-up, the treating doctors unexpectedly discover any information that affects the patient's health or quality of life, the patient will be informed immediately, even if it is unrelated to the study's purpose. All data recorded throughout the study will be stored anonymously by the study platform.

Conditions

• Chronic Heart Failure
• Heart Transplant Recipient
• Left Ventricular Assist Device

Interventions

Type	Name	Description
DEVICE	Heart monitoring tools (data revision)	data collected by the devices will be reviewed by the treating physician in the intervention group
OTHER	Control (Standard treatment)	Patients in the control group will be monitored but the information will not be available for the clinicians nor the artificial intelligence recommendations

Timeline

• Start date: 2024-04-24
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2025-06-06
• Last updated: 2026-02-04

Locations

6 sites across 4 countries: Germany, Greece, Italy, Spain