CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 154 enrolled
Drug / intervention
Telemonitoringother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05708846
NCT05708846N/ACompleted

Observational Study for the Improvement of a Digital Health Platform for Remote Monitoring of Patients With Heart Failure

humanITcare·observational·Posted Feb 1, 2023·Updated Apr 9, 2025

In Brief

An observational study evaluating Telemonitoring for Heart Failure. Completed, enrolled 154 participants across 7 sites in 2 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesRomania, Spain

Timeline

N/ACompletedFinished
2023202420252026
First PostedFeb 1, 2023
Enrollment StartMay 18, 2023
Primary CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 3.4 years ago

Interventions

Telemonitoringother

All patients will be telemonitored in order to create a labeled and diverse dataset that will include the following data: Physiological parameters (measured periodically), socio-demographic data, risk factors, medication tracking, symptomatology questionnaire for patients, NYHA-class, clinical interventions, health questionnaire answers, classified alarms with their respective timestamp and annotation by the MD, and measurement ranges for each personalized alarm and their changes