Adaptive Servo-ventilation Monitoring Study

ResMed40 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Heart Failure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sleep Laboratory, Ruhr University of Bochum

Bad Oeynhausen, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

Correlation of hypoxemia, as measured by overnight pulse oximetery, with worsening heart failure

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

Time frame: 12 months

Data from ClinicalTrials.gov

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