Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System

Not Applicable

• Conditions: Heart Failure
• Interventions: Device: "Pneumedicare"s monitoring system.; Device: "Pneumedicare"s monitoring system

• Registration Number: NCT01377350
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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

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.

Study Timeline

• Status Verified: 2011-03
• Study First Submitted: 2011-05-18
• Study Start: 2011-06
• Study First Submitted QC: 2011-06-20
• Last Update Submitted: 2011-06-20
• Study First Posted: 2011-06-21
• Last Update Posted: 2011-06-21
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
"Pneumedicare"s monitoring system	"Pneumedicare"s monitoring system.	Single arm study - "Pneumedicare"s monitoring system is used for monitoring heart failure patients
"Pneumedicare"s monitoring system	"Pneumedicare"s monitoring system	Single arm study - "Pneumedicare"s monitoring system is used for monitoring heart failure patients

Primary Outcome Measures

Name	Time	Method
earliest non-invasive signs for lung congestion and deterioration in the heart failure	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.

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel