Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2012

Detailed Description

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.

Interventions

  • Device: “Pneumedicare”s monitoring system.
    • 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.
  • Device: “Pneumedicare”s monitoring system
    • 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.

Arms, Groups and Cohorts

  • Experimental: “Pneumedicare”s monitoring system
    • Single arm study – “Pneumedicare”s monitoring system is used for monitoring heart failure patients

Clinical Trial Outcome Measures

Primary Measures

  • earliest non-invasive signs for lung congestion and deterioration in the heart failure
    • Time Frame: 18 months
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rambam Health Care Campus
  • Provider of Information About this Clinical Study
    • Shmuel Rispler, Rambam Health Care Campus, P.O.B. 9602, Haifa 31096, Israel
  • Overall Official(s)
    • Shmuel Rispler, MD PhD, Principal Investigator, Rambam Medical Center Haifa Israel
  • Overall Contact(s)
    • Shmuel rispler, MD PhD, 972-4-8542180, s_rispler@rambam.health.gov.il

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