I27.0 I27.20
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: a. Age > 18 years (no age limit) b. able to consent c. Diagnosis of Nizza class I pumonary arterial Hypertension -PAH- according to the most recent Guidelines of the European Society of Cardiology (ESC); >12 weeks since the diagnosis of 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 PAH -where there was no treatment with combination therapy in PAH patients then the reason must be documented
Exclusion criteria
Exclusion criteria: - secondary (postcapillary) pulmonary hypertension (mean pulmonary arterial hypertension > 25 mmHg; PCWP >15 mmHg) - 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 - psychiatric pre-existing conditions - contraindications to (cardiac) magnetic resonance imaging (MRI)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence (type and severity) of sleep disordered breathing (SDB) [no SDB vs. obstructive SDB vs. central SDB; mild vs. moderate vs. severe] | — |
Secondary
| Measure | Time frame |
|---|---|
| Apnoea-Hypopnoea-Index on polygraphic recording [/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], rightventricular ejection fraction on MRI [%], leftventricular ejection fraction on MRI [%], hypercapnic ventilatory Response testing [l/min/mmHg endexspiratory CO2], modified Borg Dyspnoea Scale [points], Epworth Sleepiness Scale [points], Berlin Sleep Apnoea Questionaire [points], Pittsburgh Sleep Quality Index [points], Minnesota Living with Heart Failure Questionaire [points], modified Fatigue Severity Scale [points], Medical Research Council Breathlessness Scale [points], vital capacity [ml], FEV1/FVC [%], maximal inspiratory pressure [cmH2O], maximaler exspiratory pressure [cmH2O], pO2 [mmHG], pCO2 [mmHG], 6 MWD [m], Outcome after 12 months [date of death; date of hospital admission due to heart failure], Outcome after 24 months [date of death; date of hospital admission due to heart failure] | — |
Countries
Germany
Contacts
Department für Neurologie-Klinik für Schlafmedizin und neuromuskuläre Erkrankungen Universitätsklinikum Münster