HAPH Registry: Time Course and Prognostic Significance of Pulmonary Artery Pressure in Highlanders.
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Zurich
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Permanently living >2500 m
Written informed consent
Disqualifiers
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)
Trial population
Highlanders living at Aksay plateau will be invited to participate.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 2 trial groupsGroup A: Highlanders living above 2500 m
Group B: Low altitude control
Trial outcomes
Primary outcomes
1
Change in pulmonary artery pressure in highlanders
Change in pulmonary artery pressure (RV/RA measured by echocardiography) from 2017 to 2024 in highlanders living above 2500 m.
Time frame
Year 2017 to 2024Secondary outcomes
1
Change in pulmonary artery pressure between highlanders and lowlanders
Difference in the change in pulmonary artery pressure (RV/RA measured by echocardiography) from 2017 to 2024 between highlanders and lowland controls.
Time frame
Year 2017 to 20242
Change in TRP/CO in highlanders
Change in TRP/CO slope from 2017 to 2024 in highlanders living above 2500 m.
Time frame
Year 2017 to 20243
Progression of oxygen desaturation index
Change in the oxygen desaturation index from 2017 to 2024 in highlanders.
Time frame
Year 2017 to 20244
Progression of quality of life
Change in the mental and physical component score of the SF-36 questionnaire from 2017 to 2024 in highlanders.
Time frame
Year 2017 to 2024Locations
Sponsors and contacts
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University of Zurich
Lead sponsor
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: