Not yet recruitingNCT06489730Updated Jul 8, 2024

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

An observational study in High Altitude Pulmonary Hypertension and Sleep Apnea, sponsored by University of Zurich. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-08.

Sponsored by University of Zurich · Observational

From the registry’s dates

Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as not yet recruiting.

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 120
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

High Altitude Pulmonary Hypertension
Sleep Apnea

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Keywords

high altitude illness
pulmonary hypertension
sleep apnea
disease progression
hypoxia

In context

Sleep Apnea Syndromes

2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.

This study's planned enrollment of 120 is above the median of 109 across 654 observational studies indexed under Sleep Apnea Syndromes.

Browse Sleep Apnea Syndromes studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Probability sample

Study population

Highlanders living at Aksay plateau will be invited to participate.

Inclusion criteria

Permanently living >2500 m
Written informed consent

Exclusion criteria

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

Observational model: Cohort
Time perspective: Prospective
Enrollment: 120 participants (estimated)
Target follow-up: 7 Years
Patient registry: Yes

Groups and cohorts

Highlanders living above 2500 m
Highlanders permanently living above 2500 m in the Aksay area in Kyrgyzstan
Low altitude control
Healthy lowlanders living below 1000 m.

What researchers measure

Primary outcomes

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 2024

Secondary outcomes

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 2024
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 2024
Progression of oxygen desaturation index
Change in the oxygen desaturation index from 2017 to 2024 in highlanders.
Time frame: Year 2017 to 2024
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 2024
Progression of arterial blood gases
Change in the arterial blood gases from 2017 to 2024 in highlanders.
Time frame: Year 2017 to 2024
Progression of right heart strain
Change in the right heart strain from 2017 to 2024 in highlanders.
Time frame: Year 2017 to 2024

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06489730
Lead sponsor: University of Zurich
Collaborators: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Responsible party: Sponsor
First posted: Jul 8, 2024
Start date: Jul 1, 2024 (estimated)
Primary completion: Dec 31, 2024 (estimated)
Completion: Dec 31, 2024 (estimated)
Last update: Jul 8, 2024

Study contacts

Silvia Ulrich, Prof. Dr.

Contact

silvia.ulrich@usz.ch

+41442552220

Michael Furian, Prof. Dr.

Contact

michael.furian@usz.ch

+41442552220

Talant M Sooronbaev, Prof. Dr.

principal investigator · National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

Silvia Ulrich, Prof. Dr.

principal investigator · University Hospital Zurich, Department of Pulmonology

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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