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

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

• Hannover Medical School

  collaborator OTHER

• Attikon Hospital

  collaborator OTHER

• IRCCS Azienda Ospedaliero-Universitaria di Bologna

  collaborator OTHER

• Onassis Cardiac Surgery Centre

  collaborator OTHER

• Hospital Universitario Ramon y Cajal

  collaborator OTHER

• Puerta de Hierro University Hospital

  lead OTHER

Principal Investigators

• Maria Haritou, PhD · ICCS

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-24

Primary Completion

2026-08-31

Completion

2026-08-31

Countries

• Germany
• Greece
• Italy
• Spain

Study Locations