Heart Failure Clinical Trial
Official title:
ECG Derived Respiration for Automated Screening of Sleep Disordered Breathing in Chronic Heart Failure Patients
The prevalence of sleep disordered breathing (SDB) reaches more than 50% in chronic heart failure patients (CHF). The main consequence is an increase risk of fatal and non-fatal cardiovascular events. A treatment by continuous positive airway pressure (CPAP) or adaptative servo-ventilation (ASV) reduces this risk. Nevertheless, 75% of severe SDB cases remains undiagnosed and untreated especially due to cost and time delay for polysomnography examination which is the gold standard for SDB diagnosis. Indeed, alternative methods are developed. Some methods, based on nocturnal ECG analysis showed promising results but they are not validated and adapted for cardiac population. Thus, the goal of present study is to test the accuracy of ECG derived respiration signal to screen SDB in a CHF population.
Status | Completed |
Enrollment | 100 |
Est. completion date | November 2014 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - chronic heart failure - left ventricular ejection fraction < 45% - New York Heart Association (NYHA) index = 2 - Sleep apnea syndrom confirmed by polysomnography Exclusion Criteria: - Chronic Obstructive Pulmonary Disease with maximal Respiratory Volume < 50% - Resting oxygen saturation < 90% - Continuous Positive Airway Pressure (CPAP) or Adaptive Servo-Ventilation treatment - Life expectancy < 1 year for other medical reasons than heart failure - Cardiac surgery - Percutaneous transluminal coronary angioplasty - Unstable angora during the 6 last months - Implantation of a pacemaker or a defibrillator during the 6 last months - Cerebrovascular accident or Transient Ischemic Attack during the 3 last months - Restless legs syndrome - Acute myocarditis or pericarditis during the 6 last months - Valvular disease - Pregnancy |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
France | CHU de Grenoble | Grenoble | |
France | CHU de Saint-Etienne | Saint-etienne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Apnea Hypopnea Index (AHI) | Standard nocturnal in-home ventilatory polygraphic recordings. The AHI is calculated only on nocturnal ECG analysis | At patient polygraphic recording | No |
Secondary | AHI in subgroup patient with sinusal rhythm | At patient polygraphic recording | No | |
Secondary | AHI in subgroup with implanted pacemaker | At patient polygraphic recording | No | |
Secondary | AHI in subgroup with atrial fibrillation | At patient polygraphic recording | No | |
Secondary | AHI in subgroup with bundle branch block | At patient polygraphic recording | No |
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