Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Trial ID: NCT07008729
Status: ACTIVE_NOT_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2024-04-24
Completion date: 2026-08-31
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
Interventions: Heart monitoring tools (data revision); Control (Standard treatment)
Locations: Medizinische Hochschule Hannover ('Mhh'); National and Kapodistrian University of Athens; Onassis Cardiac Surgery Center; Alma Mater Studiorum - Universita Di Bologna; Hospital Universitario Puerta de Hierro; Hospital Universitario Ramón Y Cajal
Countries: Germany; Greece; Greece; Italy; Spain; Spain
Enrollment: 390
Age range: 18 Years - 75 Years
Sex: ALL

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.

Eligibility criteria:
Inclusion Criteria:

* Age of 18-75 years.
* Ability to understand and provide consent in order to participate in the study.
* Have a cognitive assessment score of \> 22 as assessed by the Montreal Cognitive Assessment (MoCA), ( adults without or with mild cognitive impairment at most).
* Have a depression score as assessed by Personal Health Questionnaire-9 (PHQ-9) score \< 10.
* Provide written informed consent.
* For Heart Failure patients: 1) have a diagnosis of symptomatic heart failure (class II or III according to the New York Heart Association Classification); 2) have echocardiographically determined left ventricular ejection fraction (LVEF) ≤40%; 3) have been hospitalized due to cardiovascular reasons or had urgent visit to the Emergency Department due to decompensated HF that required administration of intravenous diuretics within the last 12 months before randomization (Currently hospitalized patients can be included provided they do not fulfill exclusion criterion of being currently with in-hospital administration of IV diuretics/vasoactive/inotropic drugs).
* For patients with ventricular assist devices (VAD): have left ventricular assist device (LVAD) implanted either as destination therapy or as bridge-to-transplantation, within at least 90 days and no longer than 48 months before randomization
* for heart transplant recipients: have been discharged following heart transplantation within at least 30 days and no longer than 36 months before study randomization.

Exclusion Criteria:

* Is clinically unstable at the time of randomization as defined by: administration of intravenous diuretics during the last 12 hours or intravenous vasodilators or inotropes during the last 48 hours before randomization.
* Has acute coronary syndrome within the last 30 days before randomization.
* Has acute inflammatory heart disease, (for instance, acute myocarditis), within 90 days prior to randomization.
* Has a planned revascularisation, cardiac resynchronization therapy (CRT) implantation or any valvular procedures within 3 months after randomization
* Has known current alcohol or illicit drug abuse.
* Shows significant impairment or unwillingness to use the telemonitoring equipment (for instance, dementia, impaired self-determination, lacking ability to communicate).
* Has any severe non-cardiovascular disease limiting life expectancy to less than 1 year.
* Is pregnant.
* Participates currently in other telemonitoring programs/studies using smart devices

Outcomes:
Difference in days lost due to unplanned cardiovascular hospitalizations or all-cause death between groups; Differences in the rates of occurrence of death or unplanned hospitalization/ambulatory administration of intravenous (iv) diuretics, iv antibiotics or iv steroids