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Artificial Intelligence and Smart Wearable Technologies for Early Detection of Acute Heart Failure

NCT05591443 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2022-10-24

No results posted yet for this study

Summary

Heart failure is the major pandemic of the 21st century. The number of patients and of Heart Failure-related deaths is progressively increasing. This means a devastating economic and health organization burden. In fact, chronic heart failure patients are at high risk of death, and the course of the disease is often insidious and uncertain with a progressive deterioration requiring the need for repeated and successive hospitalizations with an ominous prognosis: with each admission for acute heart failure there is a short-term improvement, a phase characterized by a degree of stability, and then a worsening phase follows until a new need for a new hospitalization. Moreover, with each subsequent hospitalization, myocardial function progressively declines, gradually worsening the patient's quality of life until the fatal event.

For these reasons, one of the major unmet needs is the identification of patients with a negative trajectory of Heart Failure. Accordingly, early identification of Heart Failure worsening is mandatory to improve patient condition and reduce Heart Failure costs, which are mainly associated with hospitalizations.

Our main goal through this project is to create clinical tool for detection of early signs of chronic heart failure (CHF) worsening that will allow timely therapeutic intervention. This timely manner intervention can lead to a much better outcome for the patient, possibly reducing the need for hospitalization or lower the number of hospitalization days.

The aim of this project is to develop clinical decision tool based on artificial intelligence (AI) algorithms to early detect the signs of exacerbation of chronic heart failure and predict the risk of its progression, by integrating high quality medical data obtained through a wearable device (L.I.F.E. Italia Srl's "wearable clinic" - a vest with accessories, which is a TRL 9 medical grade sensorized garment, already available on the market). Specifically, the focus will be on the early detection of CHF worsening in patients who have already been diagnosed with CHF.

Conditions

  • Heart Failure，Congestive

Sponsors & Collaborators

  • Centro Cardiologico Monzino

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2025-05-31
Completion
2026-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05591443 on ClinicalTrials.gov