Intraindividual Cardiopulmonal Adaptation to hypobaric hypoxia while long-distance flight Simulation in PH-patients

Not Applicable

• Conditions: I27.0; Primary pulmonary hypertension

• Registration Number: DRKS00028924
• Lead Sponsor: niklinik Köln

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-14
• Study Completion: 2024-06-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Signed informed consent form
- Clinically stable disease for more than 3 months, assessed by the investigator
- Right heart catheterisation with assessment of intracardiac blood pressure and haemodynamics within the last 24 months with PAPmean = 20 mmHg
- Pulmonary hypertension with stable specific therapy for at least 4 weeks (Nice Class I), or pulmonary hypertension with left heart disease (Nice Class II), or chronic thromboembolic pulmonary hypertension (Nice Class IV)

Exclusion Criteria

- Hospitalisation due to cardiac decompensation within the last 3 months
- Planned PTCA, ICD implantation, ACVB surgery within the next 90 days
- Previous PTCA, cerebrovascular event (TIA, stroke) within the last 90 days
- Hb < 8 g/dl
- Resting PaO2 =7.3 kPA with LTOT therapy > 16 h/day (nocturnal oxygen administration permitted)
- Chronic pleural effusion
- Acute infectious disease, especially respiratory disease
- Women who are pregnant or breastfeeding
- Inability to follow the study procedures, e.g. due to speech problems, mental disorders, neurological or orthopaedic problems

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Difference in the maximum intraindividual change versus baseline in O2 saturation (capillary ABG measurement*; measured at 2-hour intervals, measured after 5 minutes of sitting) during the observation period of 8 hours of hypobaric hypoxia compared to normobaric normoxia (control)<br>- Difference in the maximum intraindividual change versus baseline of the ESQ IV symptom score (total score of the relevant components AMS-C, AMS-R, exertion, fatigue; measured in 4-hour intervals) during the observation period of 8 hours of hypobaric hypoxia compared to normobaric normoxia (control)