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Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System

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ClinicalTrials.gov Identifier: NCT01377350
Recruitment Status : Unknown
Verified March 2011 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : June 21, 2011
Last Update Posted : June 21, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: "Pneumedicare"s monitoring system. Device: "Pneumedicare"s monitoring system Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System
Study Start Date : June 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: "Pneumedicare"s monitoring system
Single arm study - "Pneumedicare"s monitoring system is used for monitoring heart failure patients
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.
Other Name: "Pneumedicare"s monitoring system for heart failure patients

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.
Other Name: "Pneumedicare"s monitoring system for heart failure patients




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01377350


Contacts
Contact: Shmuel rispler, MD PhD 972-4-8542180 s_rispler@rambam.health.gov.il
Contact: Amir Landesberg, MD PhD 972-505482249 Amir@bm.technion.ac.il

Locations
Israel
Rambam Health Care Campus Not yet recruiting
Haifa, Israel, 31096
Contact: Shmuel Rispler, MD PhD    972-4-8542180    s_rispler@rambam.health.gov.il   
Contact: Amir Landesberg, MD PhD    972-505482249    Amir@bm.technion.ac.il   
Principal Investigator: Shmuel Rispler, MD PhD         
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Shmuel Rispler, MD PhD Rambam Medical Center Haifa Israel

Responsible Party: Shmuel Rispler, Rambam Health Care Campus, P.O.B. 9602, Haifa 31096, Israel
ClinicalTrials.gov Identifier: NCT01377350     History of Changes
Other Study ID Numbers: 0550-10ctil
ministry of health Israel ( Other Identifier: ministry of health Israel )
First Posted: June 21, 2011    Key Record Dates
Last Update Posted: June 21, 2011
Last Verified: March 2011

Keywords provided by Rambam Health Care Campus:
Heart failure
monitoring

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases