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

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03165019
• Other study ID #: 01-8/433
• Status: Completed
• Start date: May 24, 2017
• Est. completion date: August 16, 2017

Study information

• Verified date: August 2019
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 participated in the study in 2012 to undergo follow-up examinations in 2017, in order to allow comparisons of current results with baseline data from 2012.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: August 16, 2017
• Est. primary completion date: August 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• high altitude pulmonary hypertension confirmed by clinical presentation and mean pulmonary artery pressure >30 mmHg measured by echocardiography at altitude of residence.

• healthy subjects (high altitude controls)

• Both genders

• Age >16 y

• Kyrgyz ethnicity

• born, raised and currently living at >2500 m

• healthy subjects currently living at <1000 m (low altitude controls)

Exclusion Criteria:

• Pulmonary hypertension from other causes, in particular from left ventricular failure as judged clinically and by echocardiography

• Excessive erythrocytosis

• Other coexistent disorders that may interfere with the cardio-respiratory system and sleep

• Regular use of medication that affects control of breathing

• Heavy smoking

Related Conditions & MeSH terms

• Altitude Sickness
• High Altitude Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary
• Sleep Apnea
• Sleep Apnea Syndromes

Locations

Country	Name	City	State
Kyrgyzstan	National Center for Cardiology and Internal Medicine	Bishkek

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	National Center of Cardiology and Internal Medicine, Kyrgyzstan

Country where clinical trial is conducted

Kyrgyzstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in pulmonary artery pressure	Difference in the change in mean pulmonary artery pressure (mPAP measured by echocardiography) 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander	Year 2012 to 2017
Secondary	Changes in nocturnal arterial oxygen saturation	Difference in the change in the nocturnal arterial oxygen saturation 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander	Year 2012 to 2017
Secondary	Survival	Cumulative incidence of death and relocation to lower altitudes between 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander	Year 2012 to 2017
Secondary	Progression of oxygen desaturation index	Difference in the change in the oxygen desaturation index 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander	Year 2012 to 2017
Secondary	Progression of quality of life	Difference in the change in the mental and physical component score of the SF-36 questionnaire 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander	Year 2012 to 2017
Secondary	Progression of cognitive performance	Difference in the change in the mean reaction time 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander	Year 2012 to 2017
Secondary	Exercise performance	Difference in the change in 6 minute walk distance 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander	Year 2012 to 2017
Secondary	Arterial blood gas analysis	Difference in the change in arterial blood gases 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander	Year 2012 to 2017