Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System

Study Overview
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Brief Summary
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The purpose of this study is to explore the feasibility of monitoring hemodynamic changes, which result from heart failure exacerbations, by recording the respiratory effort, chest wall dynamics and quantifying the development of dyspnea by using miniature mechanical sensors that are attaches to the chest.

Detailed Description
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Pulmonary veins congestion and fine changes in alveolar transudative effusion accumulation affect lung mechanics (compliance) and the respiratory effort. Moreover, the associated state of oxygen de-saturation is compensated by an increase in the respiratory effort. These changes in the respiratory effort are reflected in chest wall dynamics and may provide the earliest non-invasive sign for lung congestion and deterioration in the heart failure. The research system comprises of patches attached to the patients' thorax that include motion sensors (Accelerometers) that measure the chest wall dynamics and the mechanics of lung inflation and deflation. The signals are acquired by a miniaturized device that amplifies and samples the signals, stores and analyzes the data and displays the trends on the screen.

Official Title
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Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Pneumedicares monitoring system.
* Device: Pneumedicares monitoring system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute decompensated HF Decompensated chronic HF in patients with NYHA class III-IV symptoms Age over 20 years Ejection fraction reduced below 35% OR doppler evidence of impaired left ventricular diastolic filling Exclusion Criteria: Inability or unwillingness to follow the study protocol

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pneumedicares monitoring system<br>Single arm study - Pneumedicares monitoring system is used for monitoring heart failure patients | Device: Pneumedicares monitoring system.<br>* 50 patients hospitalized due to the decompensated HF are considered for entry. 3 patches will be attached to the patients' thorax that include motion sensors. The system will be attached to the patients at the start of treatment. Patient's signals will be recorded during the entire treatment in the hospital, to the point that there is an improvement in their health condition.<br>* Other names: Pneumedicares monitoring system for heart failure patients;Device: Pneumedicares monitoring system<br>* Non invasive clinical follow-up of patients with HF deterioration and improvement, by a device-based algorithm. The system comprises of patches attached to the patients' thorax that include motion sensors (Accelerometers) that measure the chest wall dynamics and the mechanics of lung inflation and deflation.<br>* Other names: Pneumedicares monitoring system for heart failure patients;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| earliest non-invasive signs for lung congestion and deterioration in the heart failure | Exploring the feasibility of monitoring hemodynamic changes, which result from heart failure exacerbations, by recording the respiratory effort, chest wall dynamics and quantifying the development of dyspnea by using miniature mechanical sensors that are attaches to the chest. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, monitoring