Adaptive Servo-ventilation Monitoring Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sleep Laboratory, Ruhr University of Bochum

Bad Oeynhausen, North Rhine-Westphalia, D-32545, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2016
First posted: May 8, 2014
Registry last updated: Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed