Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System

Heart Failure Clinical Trial

Official title:

Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01377350
• Other study ID #: 0550-10ctil
• Secondary ID: ministry of heal
• Status: Not yet recruiting
• Phase: N/A
• First received: May 18, 2011
• Last updated: June 20, 2011
• Start date: June 2011
• Est. completion date: December 2012

Study information

• Verified date: March 2011
• Source: Rambam Health Care Campus
• Contact: Shmuel rispler, MD PhD
• Phone: 972-4-8542180
• Email: s_rispler[@]rambam.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.
• "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.

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No