Adaptive Servo-ventilation Monitoring Study

Chronic Heart Failure Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02133859
• Other study ID #: MA220414
• Status: Completed
• Phase: N/A
• First received: May 1, 2014
• Last updated: April 26, 2017
• Start date: May 2014
• Est. completion date: March 2016

Study information

• Verified date: April 2017
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Locations

Country	Name	City	State
Germany	Sleep Laboratory, Ruhr University of Bochum	Bad Oeynhausen	North Rhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months