HAPH Registry: Time Course and Prognostic Significance of Pulmonary Artery Pressure in Highlanders.

Not yet recruiting

• Conditions: High Altitude Pulmonary Hypertension; Sleep Apnea

• Registration Number: NCT06489730
• Lead Sponsor: University of Zurich

Brief Summary

The purpose of the current study is to evaluate the clinical and physiologic course of Kyrgyz highlanders with high altitude pulmonary hypertension (HAPH) by performing a longitudinal cohort study. To this end, the investigators will invite the same highlanders who participate din the study in 2017 to undergo follow-up examinations in 2024, in order to allow comparisons of current results with baseline data from 2017.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-06-28
• Last Update Submitted: 2024-06-28
• Study Start: 2024-07-01
• Study First Posted: 2024-07-08
• Last Update Posted: 2024-07-08
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Permanently living >2500 m
• Written informed consent

Exclusion Criteria

• Highlanders who cannot follow the study investigations,
• Patients with moderate to severe concomitant lung disease (FEV1<70% or forced vital capacity <70%), severe parenchymal lung disease, heavy smoking >20 cigarettes/day or >20 pack-years.
• Coexistent unstable systemic hypertension or coronary artery disease that required adjustment of medication within the last 2 months
• Regular use of medication that affects control of breathing (benzodiazepines, opioids, acetazolamide)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in pulmonary artery pressure in highlanders	Year 2017 to 2024	Change in pulmonary artery pressure (RV/RA measured by echocardiography) from 2017 to 2024 in highlanders living above 2500 m.

Secondary Outcome Measures

Name	Time	Method
Change in pulmonary artery pressure between highlanders and lowlanders	Year 2017 to 2024	Difference in the change in pulmonary artery pressure (RV/RA measured by echocardiography) from 2017 to 2024 between highlanders and lowland controls.
Progression of quality of life	Year 2017 to 2024	Change in the mental and physical component score of the SF-36 questionnaire from 2017 to 2024 in highlanders.
Change in TRP/CO in highlanders	Year 2017 to 2024	Change in TRP/CO slope from 2017 to 2024 in highlanders living above 2500 m.
Progression of oxygen desaturation index	Year 2017 to 2024	Change in the oxygen desaturation index from 2017 to 2024 in highlanders.
Progression of arterial blood gases	Year 2017 to 2024	Change in the arterial blood gases from 2017 to 2024 in highlanders.
Progression of right heart strain	Year 2017 to 2024	Change in the right heart strain from 2017 to 2024 in highlanders.