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

• Sponsor: University of Zurich (Other)
• Overall Status: Completed
• CT.gov ID: NCT03165019
• Collaborator: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov (Other)
• Enrollment: 165
• Location: 1
• Actual Duration (Months): 2.8
• Patients Per Site Per Month: 59.8

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
High Altitude Pulmonary Hypertension; Sleep Apnea

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 165 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Time Course and Prognostic Significance of Pulmonary Artery Pressure in Highlanders.
• Actual Study Start Date: May 24, 2017
• Actual Primary Completion Date: Aug 16, 2017
• Actual Study Completion Date: Aug 16, 2017

Arms and Interventions

Arm	Intervention/Treatment
High altitude pulmonary hypertension Highlanders with high altitude pulmonary hypertension living above 2500 m.
High altitude control Healthy highlanders living above 2500 m.
Low altitude control Healthy lowlanders living below 1000 m.

Outcome Measures

Primary Outcome Measures

1. Changes in pulmonary artery pressure [Year 2012 to 2017]

   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

Secondary Outcome Measures

1. Changes in nocturnal arterial oxygen saturation [Year 2012 to 2017]

   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

2. Survival [Year 2012 to 2017]

   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

3. Progression of oxygen desaturation index [Year 2012 to 2017]

   Difference in the change in the oxygen desaturation index 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander

4. Progression of quality of life [Year 2012 to 2017]

   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

5. Progression of cognitive performance [Year 2012 to 2017]

   Difference in the change in the mean reaction time 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander

6. Exercise performance [Year 2012 to 2017]

   Difference in the change in 6 minute walk distance 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander

7. Arterial blood gas analysis [Year 2012 to 2017]

   Difference in the change in arterial blood gases 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Center for Cardiology and Internal Medicine	Bishkek		Kyrgyzstan	720040

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Talant M Sooronbaev, MD, NCCIM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT03165019
• Other Study ID Numbers: 01-8/433
• First Posted: May 24, 2017
• Last Update Posted: Aug 16, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Zurich: high altitude illness; pulmonary hypertension; sleep apnea; disease progression; hypoxia
• Additional relevant MeSH terms: Sleep Apnea Syndromes; Hypertension, Pulmonary; Hypertension

Study Results

No Results Posted as of Aug 16, 2019