1. To assess prevalence of SAS in a Dutch chronic heart failure (CHF) population. 2. To assess whether there are group differences between CHF-patients without SAS and CHF-patients with SAS (OSAS and CSAS). 3. To assess the validity of the ApneaLink…
ID
Source
Brief title
Condition
- Heart failures
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of CHF-patients without SAS, and percentage of CHF-patients with SAS
(OSAS and CSAS). Therefore, apnea-hypopnea index (AHI) will be measured by
polysomnography.
Secondary outcome
From online medical patient*s files:
Echocardiographic parameters (i.e. left ventricular ejection fraction),
Parameters of the bicycle ergometric cardiopulmonary exercise test (Peak VO2),
Routine blood measurements (e.g. hemoglobin-level, NT-proBNP).
Additional measurements:
ApneaLink,
Blood sample assessment,
Urine sample assessment,
Excessive Daytime Sleepiness (EDS).
Background summary
Chronic heart failure (CHF) is a clinical syndrome with a high mortality and
morbidity rate, which has a 5-year survival rate of only 50% despite optimal
therapy. Moreover, CHF has a large impact on the quality of life, and leads to
high medical costs due to regular hospitalizations. A condition often seen in
CHF patients is sleep apnea syndrome (SAS). Sleep apnea can be divided into two
forms. Both obstructive sleep apnea syndrome (OSAS) and central sleep apnea
syndrome (CSAS) can occur. While SAS affects 2-4% of the middle-aged working
population, its prevalence in a CHF population is much higher (50-70%). After
adjustment for confounders, patients with both CHF and SAS have a mortality
rate twice as high as patients with only CHF. The prevalence of SAS in Dutch
patients with CHF is not known at this moment due to a changed medication
policy in heart failure. Also, only a few sleep studies are executed in this
group of patients.
Study objective
1. To assess prevalence of SAS in a Dutch chronic heart failure (CHF)
population. 2. To assess whether there are group differences between
CHF-patients without SAS and CHF-patients with SAS (OSAS and CSAS). 3. To
assess the validity of the ApneaLink.
Study design
Cross-sectional study. 100 patients with stable CHF will be screened for SAS
with polysomnography and the ApneaLink.
Study burden and risks
There is no extra risk or burden as patients with heart failure already will
have a blood sample assessment, echocardiogram and a bicycle ergometry test.
One of two additions will be a polysomnography+ApneaLink measurement as these
patients have a high chance of having SAS (OSAS or CSAS). Also, blood- and
urine samples are taken once when patients participate in the study.
Venapunction can give some burden as it can give a small local haematoma
afterwards. Measuring these parameters will give information about the presence
of SAS so that patients can be treated for this disorder when necessary.
Postbus 30001
9700 RB Groningen
NL
Postbus 30001
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
•Patients with NYHA functional class II-IV stable heart failure for at least 3 months
•Patients able to understand the procedures and are willing to provide informed consent
Exclusion criteria
•Patients aged < 18 years
•Patients who already underwent polysomnography in the previous 12 months
•History of myocardial infarction in the previous 6 months
•History of (minor) stroke in the previous 6 months
•Severe valvular dysfunction
•Severe lung disease (documented COPD GOLD 3 and 4)
•Active and/or treated malignancies within 12 months prior to inclusion
•Patients on cardial resynchronisation therapy (CRT), or scheduled for CRT
•Pregnancy or active breast feeding
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL35624.042.11 |