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Sleep-disordered-breathing in patients with precapillary pulmonary hypertension

Sleep-disordered-breathing in patients with precapillary pulmonary hypertension

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00013658
Enrollment
80
Registered
2018-03-14
Start date
2018-04-02
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I27.0 I27.20

Interventions

Group 1: - cardiac magnetic resonance imaging (MRI) (within 3 months of the investigations carried out in our laboratory of respiratory physiology) - lung function tests including blood gas analysis -

Sponsors

Universitätsklinikum Münster
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime frame
Presence (type and severity) of sleep disordered breathing (SDB) [no SDB vs. obstructive SDB vs. central SDB; mild vs. moderate vs. severe]

Secondary

MeasureTime 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

Public ContactJens Spiesshoefer

Department für Neurologie-Klinik für Schlafmedizin und neuromuskuläre Erkrankungen Universitätsklinikum Münster

jens.spiesshoefer@ukmuenster.de00491729417765

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026