Heart Failure Clinical Trial
Official title:
Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System
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.
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Israel | Rambam Health Care Campus | Haifa |
Lead Sponsor | Collaborator |
---|---|
Rambam Health Care Campus |
Israel,
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 |
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