Sleep-disordered breathing in patients with pulmonary arterial hypertension before and after effective treatment

Recruiting

• Conditions: I27.0; I27.8; I27.9; Primary pulmonary hypertension; Other specified pulmonary heart diseases; Pulmonary heart disease, unspecified

• Registration Number: DRKS00013897
• Lead Sponsor: Department für Neurologie - Klinik für Schlafmedizin und neuromuskuläre Erkrankungen (Direktor: Univ.-Prof. Dr. med. Peter Young)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

Invasively obtained diagnosis of PAH (mean pulmonary arterial pressure = 25 mmHg; post-capillary wedge pressure =15 mmHg; pulmonary vascular resistance > 3 Wood units)
-APAH due to (echocardiographically) proven congenital heart disease or due to (antinuclear antibody positive) connective tissue disease (systemic sclerosis) or IPAH with comprehensive investigations in order to exclude other causes of PAH
-No or ineffective treatment (untreated”), as defined by no clinical improvement (NYHA functional class > II) and/or persistent elevation or no near-to-normal reduction of NT-proBNP levels under current PAH medication
- Presence of SDB on cardiorespiratory polygraphy (AHI > 15/h)
-Age > 18 years and < 70 years
-Free ambulation
-Written informed consent to participate in the study

Additional inclusion criterion for post-treatment evaluation:
Positive treatment response as reflected by clinical improvement (NYHA I or II) and/or normal or near-to-normal of NT-proBNP.

Exclusion Criteria

-Body Mass Index (BMI) > 35
-Heart failure with left ventricular ejection fraction <50%
-Chronic obstructive pulmonary disease, emphysema
-Presence of severe neurological comorbidities especially primary myopathy, muscular dystrophy, motor neuron disease, phrenic nerve disease, epilepsy, multiple sclerosis, parkinson’s disease
-Severe psychiatric disease including dementia
-Thoracic wall disease
-Cardiac pacemaker

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

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