Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System
2 other identifiers
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedFirst Posted
Study publicly available on registry
June 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJune 21, 2011
March 1, 2011
1.5 years
May 18, 2011
June 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
"Pneumedicare"s monitoring system
EXPERIMENTALSingle arm study - "Pneumedicare"s monitoring system is used for monitoring heart failure patients
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Inability or unwillingness to follow the study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rambam Health Care Campus
Haifa, 31096, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shmuel Rispler, MD PhD
Rambam Medical Center Haifa Israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 18, 2011
First Posted
June 21, 2011
Study Start
June 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
June 21, 2011
Record last verified: 2011-03