Feasibilty of Respiratory Monitoring With Adaptive Servoventilation (PaceWave™) to Predict Worsening of Heart Failure in Patients With Severe Heart Failure and Sleep-disordered Breathing

ResMed1 site in 1 country40 target enrollmentMay 2014

ConditionsChronic Heart Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Heart Failure
Sponsor: ResMed
Enrollment: 40
Locations: 1
Primary Endpoint: Correlation of hypoxemia, as measured by overnight pulse oximetery, with worsening heart failure
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

March 2016

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

ResMed

Responsible Party

Sponsor

Eligibility Criteria

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