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Not Yet Recruiting NCT05708846

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

Conditions: Heart Failure

Sex: All
Ages: 18 Years – N/A
Enrollment: 500
Sponsor: humanITcare

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 discharged from an HF hospitalization in the 30 days prior to study enrollment or in the process of discharge planning.Patients have either NTproBNP > 1800 pg/ml or BNP > 400 pg/ml at the moment of hospitalization.Patients must have had an echocardiogram during their HF hospitalization.Prior to the initiation of any procedures, the hospital will ensure that an informed consent document completed by the patient is obtained, 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 ongoingPatients participating in other studies or trials.Patients not willing to participate.Patients over 150 kgPatients who do not use Catalan, Spanish, English, Portuguese, Italian, Dutch, German, Swedish, Hungarian, Romanian or French.Patients without a mobile phonePatients without internet connectionPatients with moderate or severe cognitive impairment without a competent caregiverPatients with serious psychiatric illnessPatients with planned cardiac surgeryPatients with planned heart transplantation or LVAD implant

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05708846). StuddyBuddy aggregates publicly available trial information.