To assess changes in left ventricular performance using echocardiography as well as ventricular remodelling, changes in sleep and changes in mood, anxiety and cognitive functions occurring as a result of treatment of predominant central sleep apnoea…
ID
Source
Brief title
Condition
- Other condition
- Heart failures
Synonym
Health condition
sleep disordered breathing, predominantly central sleep apnea syndrome
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the change in LV ejection fraction (EF), as measured by
Echocardiography, from baseline to 12 months comparing patients randomised to
ASV (in addition to optimal medical therapy) with those randomised to continue
with optimal medical therapy alone.
Secondary outcome
• Changes in left and right ventricular function
• Changes in LV systolic and diastolic indexed volumes
• Changes in right ventricular (RV) systolic and diastolic indexed volumes
• Changes in LV and RV mass
• Changes in LV sphericity index and LV end-systolic global wall stress
• Changes in sleep duration and sleep stages as well as arousals
• Changes in sleep-disordered breathing
• Changes in quality of life assessed by Kansas City Cardiomyopathy
Questionnaire (KCCQ)
• Changes in mental status assessed by Mini-Mental State Examination (MMSE)
• Changes in Patient Health Questionnaire-9 (PHQ-9) score and Patient Anxiety
Questionnaire GAD-7
Background summary
This protocol describes a substudy within the SERVE-HF programme, designed to
evaluate the impact of ASV on left ventricular remodelling and examine the
relationship between this and control of SDB and sleep quality. Additionally
changes in cognitive function, depression and anxiety will be investigated.
Adaptive servo-ventilation (ASV), a specific type of non-invasive ventilation,
ameliorates central sleep apnea (CSA) and by controlling sleep-disordered
breathing reduces arousals and sleep fragmentation, sympathetic stress and
normalizes oxygenation during sleep.
Study objective
To assess changes in left ventricular performance using echocardiography as
well as ventricular remodelling, changes in sleep and changes in mood, anxiety
and cognitive functions occurring as a result of treatment of predominant
central sleep apnoea by adaptive servoventilation in chronic heart failure in
addition to optimal medical therapy in chronic heart failure. This will be a
substudy of the SERVE-HF study.
Study design
This substudy is performed within the SERVE-HF Study, a randomised,
multi-centre, international trial with parallel group design, with patients
randomised to either control (optimal medical management) or active treatment
(optimal medical treatment plus use of adaptive servoventilation) in a 1:1
ratio. The randomization will be the same as in the parent study. For this
purpose, the randomization of the parent study will be stratified as to whether
a patient is included in the substudy or not.
Intervention
see for more information ABR form SERVE-HF
Study burden and risks
MRI scans are commonly performed and are generally safe. Some people may find
being inside the scanner slightly claustrophobic. The radiowaves used in MRI
can heat body tissues and metals. Increased body temperature may cause problems
in certain people. There is a slight poosibility of getting burnt if one comes
into contact with metal objects, such as metal in clothing or equipment.
Contact between the limbs can also create a burn and foam pads may be placed
between the limbs so that this doesn't happen.
If there are metal fillings in the teeth the patient may also feel a tingling
in the teeth during the scan, but this does not damage the teeth.
No additional blood tests will be taken in this substudy. Instead some extra
tests will be done on the blood we take from the patient in the main study. The
Blood tests will involve taking some blood from a vein in the arm and these can
occasionally be uncomfortable and sometimes people are left with a bruise. Very
occasionally people feel a little light headed when they have a blood sample
taken.
There are no side effects of Echocardiography nor of sleep studies.
1 Elizabeth Macarthur Drive
Bella Vista NSW 2153
AU
1 Elizabeth Macarthur Drive
Bella Vista NSW 2153
AU
Listed location countries
Age
Inclusion criteria
The inclusion criteria for the parent SERVE-HF Study apply to the sub-study:
• Patient must be at least 22 years old
• Chronic heart failure (at least 12 weeks since diagnosis) according to the currently applicable guidelines
• LVEF <= 45% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cMRI documented less than 12 weeks before randomization
• NYHA Class III or IV at the time of inclusion or NYHA Class II with at least one hospitalization for heart failure in the last 24 months.
• No hospitalization for heart failure for at least 4 weeks prior to inclusion
• Optimised medical treatment according to applicable guidelines, with no new class of disease modifying drug for more than 4 weeks prior to randomization. In case of no beta blockers or ACE inhibitors/ARB antagonists the reasons must be documented.
• Predominant central sleep apnoea (apnoea hypopnoea index > 15/hour with >= 50% central events and a central AHI >=10/hour, derived from polygraphy or polysomnography (based on total recording time), documented less than 4 weeks before randomization. Flow measurements to be performed with nasal cannula.
• Patient is able to understand fully the study information and to provide signed informed consent
Additional inclusion criteria for the substudy
• Patients must be at least 22 years old
• Predominant central sleep apnoea (apnoea hypopnoea index > 15/hour with >= 50% central events and a central AHI >=10/hour, derived from full polysomnography (based on total sleep time), documented less than 4 weeks before randomization. Flow measurements to be performed with nasal cannula
Exclusion criteria
Patient Exclusion Criteria of the Parent Study
Patients will not fulfil any of the parent SERVE-HF Study exclusion criteria:
• Significant chronic obstructive pulmonary disease with forced expiratory volume within one second < 50% of age and gender normal values, in the last 4 weeks before randomization
• Oxygen saturation at rest during the day <= 90% at inclusion
• Current use of positive airways pressure
• Life expectancy < 1 year for disease unrelated to chronic heart failure
• Cardiac surgery, percutaneous coronary intervention, myocardial infarction or unstable angina within 6 months prior to randomization
• CRT-implantation (either CRT-D or CRT-P) scheduled or within 6 months prior to randomization
• Transient ischaemic attack or stroke within 3 months prior to randomization
• Primary haemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial
• Acute myocarditis/pericarditis within 6 months prior to randomization
• Untreated or therapy refractory Restless Leg Syndrome
• Patients for whom the use of AutoSet CS / S9 VPAP Adapt may be contra-indicated according to the user*s manual of the device used
• Pregnancy
Additional exclusion criteria for the substudy
• Amyloidosis, hypertrophic obstructive cardiomyopathy or arteriovenous fistulas
• Dosage changes of diuretics more than doubled within the last 4 weeks prior to randomization
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| ClinicalTrials.gov | NCT01164592 |
| CCMO | NL39176.042.11 |