NCT02133859

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 8, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

May 1, 2014

Last Update Submit

April 26, 2017

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Chronic Heart Failure patients using ASV

Patients with chronic heart failure who are using or willing to use adaptive servo ventilation (ASV) therapy will be enrolled. Respiratory data will be collected from this group every 3 months over a 12 month period

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic Heart Failure patients using adaptive servo ventilation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sleep Laboratory, Ruhr University of Bochum

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

Location

Study Officials

  • Olaf Oldenburg, MD

    Ruhr University of Bochum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2014

First Posted

May 8, 2014

Study Start

May 1, 2014

Primary Completion

July 1, 2015

Study Completion

March 1, 2016

Last Updated

April 27, 2017

Record last verified: 2017-04

Locations

DE(1)