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

NCT06489730 | Not Yet Recruiting

• 1 other identifier: HAPH_Register
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

High Altitude Pulmonary Hypertension; Sleep Apnea

Keywords

high altitude illness; pulmonary hypertension; sleep apnea; disease progression; hypoxia

Outcome Measures

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.

  Year 2017 to 2024

Secondary Outcomes (6)

• Change in pulmonary artery pressure between highlanders and lowlanders

  Year 2017 to 2024

• Change in TRP/CO in highlanders

  Year 2017 to 2024

• Progression of oxygen desaturation index

  Year 2017 to 2024

• Progression of quality of life

  Year 2017 to 2024

• Progression of arterial blood gases

  Year 2017 to 2024

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Highlanders living at Aksay plateau will be invited to participate.

You may qualify if:

• Permanently living \>2500 m
• Written informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead
• National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov: collaborator

MeSH Terms

Conditions

Pulmonary edema of mountaineers; Sleep Apnea Syndromes; Hypertension, Pulmonary; Disease Progression; Hypoxia

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Lung Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Talant M Sooronbaev, Prof. Dr.

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

  PRINCIPAL INVESTIGATOR

• Silvia Ulrich, Prof. Dr.

  University Hospital Zurich, Department of Pulmonology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Ulrich, Prof. Dr.

CONTACT

+41442552220; silvia.ulrich@usz.ch

Michael Furian, Prof. Dr.

CONTACT

+41442552220; michael.furian@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 8, 2024
• Study Start: July 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-06