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临床试验/NCT05591443
NCT05591443尚未招募不适用

A System Based on Artificial Intelligence and Smart Wearable Technologies for Early Detection of Acute Episodes in Heart Failure Patients

Centro Cardiologico Monzino0 个研究点目标入组 120 人开始时间: 2023年5月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
主要终点
Identification of ECG predictors of heart failure worsening

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of symptoms and/or signs of HF
  • left ventricular ejection fraction (LVEF) ≤40%. LVEF values will be obtained by determining the reduced LV systolic function, by transthoracic echocardiographic assessment as recommended by European Association of Cardiovascular Imaging (EACVI) and American Society of Echocardiography position paper.
  • NYHA functional classes II-III).

排除标准

  • NYHA functional class IV,
  • Candidates for left-ventricular assist device (LVAD) or heart transplant, as per latest definition of Heart Failure Association of the ESC.
  • Recent acute coronary syndrome within 1-year prior to the date of potential enrollment,
  • Indirect echocardiographic evidence of significantly elevated pulmonary pressures
  • Clinically relevant pulmonary hypertension
  • non-adherence to optimal medical treatment for CHF

结局指标

主要结局

Identification of ECG predictors of heart failure worsening

时间窗: 6 months

Identification of which single ECG parameters are related to Heart Failure worsening among all those collected by the L.I.F.E. device.

Definition of an algorithm for heart failure worsening

时间窗: 6 months

Development by artificial intelligence of an algorithm based on all collected variables able to identify Heart Failure worsening

Identification of respiratory predictors of heart failure worsening

时间窗: 6 months

Identification of which single respiratory parameters are related to Heart Failure worsening among all those collected by the L.I.F.E. device.

次要结局

  • Heart rate variability as marker of heart failure worsening(6 months)
  • Identification of nocturnal parameters related to heart failure worsening(6 months)

研究者

发起方
Centro Cardiologico Monzino
申办方类型
Other
责任方
Principal Investigator
主要研究者

Piergiuseppe Agostoni

Professor

Centro Cardiologico Monzino

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