Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
"Pneumedicare"s monitoring system.
"Pneumedicare"s monitoring system
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure focused on measuring Heart failure, monitoring
Eligibility 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
Sites / Locations
- Rambam Health Care Campus
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
"Pneumedicare"s monitoring system
Arm Description
Single arm study - "Pneumedicare"s monitoring system is used for monitoring heart failure patients
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01377350
Brief Title
Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System
Official Title
Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, monitoring
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
"Pneumedicare"s monitoring system
Arm Type
Experimental
Arm Description
Single arm study - "Pneumedicare"s monitoring system is used for monitoring heart failure patients
Intervention Type
Device
Intervention Name(s)
"Pneumedicare"s monitoring system.
Other Intervention Name(s)
"Pneumedicare"s monitoring system for heart failure patients
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
"Pneumedicare"s monitoring system
Other Intervention Name(s)
"Pneumedicare"s monitoring system for heart failure patients
Intervention Description
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.
Primary Outcome Measure Information:
Title
earliest non-invasive signs for lung congestion and deterioration in the heart failure
Description
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.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shmuel rispler, MD PhD
Phone
972-4-8542180
Email
s_rispler@rambam.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Amir Landesberg, MD PhD
Phone
972-505482249
Email
Amir@bm.technion.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shmuel Rispler, MD PhD
Organizational Affiliation
Rambam Medical Center Haifa Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shmuel Rispler, MD PhD
Phone
972-4-8542180
Email
s_rispler@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Amir Landesberg, MD PhD
Phone
972-505482249
Email
Amir@bm.technion.ac.il
First Name & Middle Initial & Last Name & Degree
Shmuel Rispler, MD PhD
12. IPD Sharing Statement
Learn more about this trial
Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System
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