NCT02133859CompletedNot Applicable
Feasibilty of Respiratory Monitoring With Adaptive Servoventilation (PaceWave™) to Predict Worsening of Heart Failure in Patients With Severe Heart Failure and Sleep-disordered Breathing
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- ResMed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Correlation of hypoxemia, as measured by overnight pulse oximetery, with worsening heart failure
Study Overview
Brief Summary
Sleep disordered breathing is very common in patients with chronic heart failure with reported prevalence rates of 50-75%. Adaptive Servo-Ventilation (ASV) can be used to treat sleep apnea in these patients. This is an observational study to document changes in respiratory parameters in HF patients using ASV for a period of 12 months.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •More than 18 years old Chronic heart failure (at least 12 weeks since diagnosis) according to the currently applicable guidelines NYHA Class III or IV at the time of inclusion with at least one hospitalization for heart failure in the last 12 months Moderate to severe sleep apnea (AHI ≥ 15/hour). Already using or willing to use ASV-therapy and able to tolerate the mask treatment
Exclusion Criteria
- •Planned or scheduled heart valve interventions and/or CABG Untreated or therapy refractory Restless Leg Syndrome Patients for whom the use of positive airway pressure therapy may be contra-indicated because of symptomatic hypotension or significant intravascular volume depletion or pneumothorax or pneumomediastinum Pregnancy
Outcomes
Primary Outcomes
Correlation of hypoxemia, as measured by overnight pulse oximetery, with worsening heart failure
Time Frame: 12 months
Hypoxemia, as measured by pulse oximetery will be compared with heart failure status to measure if a correlation exists between hypoxemia and deterioration of heart failure
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Not Applicable
Effect of Adaptive Servoventilation on Cardiac Function in Chronic Heart Failure and Cheyne-Stokes RespirationCheyne-Stokes RespirationCentral Sleep ApneaChronic Heart FailureNCT01212705Military Institute od Medicine National Research Institute
Completed
Not Applicable
Effects of Adaptive Servoventilation in Patients With Systolic Heart Failure and Sleep-Disordered BreathingSleep Apnea SyndromesAdaptive ServoventilationHeart Failure, CongestiveNCT01657188Ruhr University of Bochum550
Completed
Not Applicable
ECG Derived Respiration for Automated Screening of Sleep Disordered Breathing in Chronic Heart Failure PatientsSleep Apnea SyndromesPolysomnographyHeart FailureNCT02116686Centre Hospitalier Universitaire de Saint Etienne100
Completed
Not Applicable
Sleep Apnea Treatment During Cardiac Rehabilitation of Congestive Heart Failure PatientsSleep Disordered BreathingHeart FailureNCT01120548French Cardiology Society300
Completed
Not Applicable
Prevalence and Dynamic of Sleep-disordered Breathing in Patients Pre and Post Heart TransplantationSleep Disordered Breathing CentralHeart TransplantationHeart FailureNCT03026634Heart and Diabetes Center North-Rhine Westfalia500