I50.1 I50.0
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: a. Age > 18 years (no age limit) (Group 1, 2 and 3) b. able to consent (Group 1, 2 and 3) c. predominant central sleep apnoea as defined as AHI>15/h and >50% central events and a central AHI >10/h derived from full overnight attended polysomnography (Group 1, 2 and 3) d. Diagnosis of Nizza class I pumonary arterial Hypertension -PAH- and heart failure with reduced ejection fraction -HFrEF- according to the most recent Guidelines of the European Society of Cardiology (ESC); >12 weeks since the diagnosis of HFrEF / PAH has been made; no hospitalisation for HF in the last 4 weeks; optimal medical therapy in accordance with the most recent Guidelines of the European Society of Cardiology (ESC) with no change in medication in the last 4 weeks and combination therapy for both PAH and HFrEF -where there was no treatment with combination therapy in PAH patients or with beta blockers or ACE Inhibitors/ARBs in HFrEF, then the reason must be documented) (Group 1 and 2) e. Controls (matched for age and gender) with idopathic central sleep apnoea with normal findings on echocardiogram, electrocardiogram and normal levels of natriuretic peptide hormone (Group 3)
Exclusion criteria
Exclusion criteria: - other severe internistic pre-existing conditions, especially insulin-dependent diabetes or severe renal impairment - severe neurological pre-existing conditions such as stroke, especially brainstem infarction - intake of opioids - severe psychiatric pre-existing conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean heart rate [bpm], high frequency component of heart rate variability [%], low frequency component of diastolic blood pressure variability [%] | — |
Secondary
| Measure | Time frame |
|---|---|
| Systolic blood pressure [mmHG], diastolic blood pressure [mmHG], stroke volume index [L/min/m²], high frequency component of diastolic blood pressure variability [%], low frequency component of heart rate variability [%], respiratory rate [/min], tidal volume [ml], minute ventilation [L/min], oxygen saturation [%], transcutaneous CO2 [mmHG], sleep stage Non-Rem I [%], sleep stage Non-Rem II [%], sleep stage Non-Rem III [%], sleep stage REM [%], Awake [%], Arousal Index [/h], rightventricular ejection fraction on MRI [%], leftventricular ejection fraction on MRI [%], hypercapnic ventilatory response testing (HCVR) [l/min/mmHG endexpiratory CO2], Apnoea-Hypopnoea-Index [/h], Hypopnoea-Index [/h], central Apnoea-Index [/h], obstructive Apnoea-Index [/h], cycle lengths of obstructive events [sec], cycle lengths of central events [sec], length of CSA-CSR [sec], modified Borg Dyspnoea Scale [Points; questionaire], Epworth Sleepiness Scale [points; questionaire], Berlin Sleep Apnoea Questionaire [points; questionaire], Pittsburgh Sleep Quality Index [points; questionaire], Minnesota Living with Heart Failure Questionaire [points; questionaire], modified Fatigue Severity Scale [points; questionaire], Medical Research Council Breathlessness Scale [points; questionaire], vital capacity [ml], FEV1/FVC [%], maximal inspiratory pressure [cmH2O], maximal exspiratory pressure [cmH2O], pO2 [mmHG], pCO2 [mmHG], 6 MWD (6 Minute Walk Distance) [m] | — |
Countries
Germany
Contacts
Klinik für Schlafmedizin und neuromuskuläre Erkrankungen Universitätsklinikum Münster