Clinical trial NCT02116686: ECG Derived Respiration for Automated Screening of Sleep Disordered Breathing in Chronic Heart Failure Patients
Official title: ECG Derived Respiration for Automated Screening of Sleep Disordered Breathing in Chronic Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Sleep Apnea Syndromes
Polysomnography
Keywords: chronic heart failure
Polysomnography
Sleep Apnea Syndromes
Electrocardiogram
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2014-04-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart failure patients with sleep apnea syndrom

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Apnea Hypopnea Index (AHI)
timeFrame: At patient polygraphic recording
Secondary outcomes:
measure: AHI in subgroup patient with sinusal rhythm
timeFrame: At patient polygraphic recording
measure: AHI in subgroup with implanted pacemaker
timeFrame: At patient polygraphic recording
measure: AHI in subgroup with atrial fibrillation
timeFrame: At patient polygraphic recording
measure: AHI in subgroup with bundle branch block
timeFrame: At patient polygraphic recording
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU de Grenoble
city: Saint-etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Frederic ROCHE, MD PhD
role: STUDY_DIRECTOR
References: