Observational Study for the Improvement of a Digital Health Platform for Remote Monitoring of Patients With Heart Failure
Trial ID: NCT05708846
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2023-05-18
Completion date: 2024-12-31
Sponsor: humanITcare
Collaborators: European Innovation Council; Hospital Universitario de Torrevieja; University of Barcelona
Conditions: Heart Failure
Interventions: Telemonitoring
Locations: Hospital of Galati; Hospital Floreasca; Colentina Hospital; Hospital Universitario de Torrevieja; Hospital de Figueres; Hospital General Universitario Nuestra Señora del Prado; Hospital Universitari de Girona Doctor Josep Trueta
Countries: Romania; Romania; Romania; Spain; Spain; Spain; Spain
Enrollment: 154
Age range: 18 Years - None
Sex: ALL

Summary:
In the present project, we propose to run an observational study in order to create a huge dataset with telemonitoring data from heart failure (HF) patients. The dataset will contain physiological measurements, socio-demographic data, risk factor information, medication tracking, symptomatology, clinical events and health-related questionnaire answers from each patient. Furthermore, health-related alarms will be delivered to the medical professionals whenever a measure from a patient is out of a predefined clinical range. These alarms and its defined level of relevance (indicated by the medical professionals) will also be Included in the dataset. With the annotated dataset we will be able to implement and train Machine Learning (ML) models that will improve the alarm-based system by making it more robust, trustworthy and reliable.

Eligibility criteria:
Inclusion Criteria:

* Heart failure (HF) patients with NYHA Functional Class \>= II (according to 2021 EU guidelines).
* Patients older than 18 years old.
* Patients who have suffered an acute decompensation of HF (first and recurrent) in the 30 days prior to enrollment in the study.
* NT-pro BNP ≥300 pg/ml at the moment of hospitalization for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter, NT-pro BNP must be ≥600 pg/mL
* Patients must have had an echocardiogram during their HF hospitalization or in the previous 12 months.
* Prior to initiating any procedures, the hospital will ensure that the patient obtains an informed consent document, if applicable.
* All patients will be eligible regardless of the level of LVEF: HFrEF, HFmrEF, and HFpEF.

Exclusion Criteria:

* Oncology patients with metastasis or with chemotherapy treatment ongoing
* Patients participating in other studies or trials.
* Patients not willing to participate.
* Patients over 150 kg
* Patients who do not use Catalan, Spanish, English, Portuguese, Italian, Dutch, German, Swedish, Hungarian, Romanian or French.
* Patients without a mobile phone
* Patients without internet connexion
* Patients with moderate or severe cognitive impairment without a competent caregiver
* Patients with serious psychiatric illness
* Patients with planned cardiac surgery
* Patients with planned heart transplantation or LVAD implant

Outcomes:
Number of Patients Included in the Dataset; Implement ML Models to Improve the Current Alarm-based System Using the Dataset Created