Right Ventricular Function at Rest in Highlanders/Lowlanders

Right Ventricular Function at Rest in Highlanders With Pulmonary Hypertension Compared to Highlanders Without Pulmonary Hypertension and Lowlanders

The purpose of the current study is to evaluate the progression of right ventricular function and dimension in Kyrgyz highlanders with high altitude pulmonary hypertension (HAPH) by performing a cross sectional case-control study.

Study Overview

• Status: Completed
• Conditions: High Altitude Pulmonary Hypertension

• Study Type: Observational
• Enrollment (Actual): 173

Contacts and Locations

Study Locations

• Kyrgyzstan
  • Bishkek, Kyrgyzstan, 720040
    • National Center for Cardiology and Internal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Highlanders with high altitude pulmonary hypertension living at an altitude of 2500-4000 m; healthy highlanders living at an altitude of 2500-4000 m; healthy lowlanders living at an altitude of <1000 m.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary artery pressure	Difference between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders in tricuspid pressure gradient, measured by transthoracic echocardiography	Day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac output	Difference between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders in cardiac output, measured by transthoracic echocardiography	Day 2
right heart dimensions	Difference of right heart dimensions between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders, measured by transthoracic echocardiography	Day 2
Right heart function	Differences of right heart function between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders, measured by transthoracic echocardiography (TAPSE)	Day 2
stroke volume	Difference between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders in stroke volume, measured by transthoracic echocardiography	Day 2
volumes	Difference of volumes between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders, measured by transthoracic echocardiography	Day 2

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
• Investigators: Study Chair: Talant M Sooronbaev, MD, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

Publications and helpful links

General Publications

• Gosens R, Hiemstra PS, Adcock IM, Bracke KR, Dickson RP, Hansbro PM, Krauss-Etschmann S, Smits HH, Stassen FRM, Bartel S. Host-microbe cross-talk in the lung microenvironment: implications for understanding and treating chronic lung disease. Eur Respir J. 2020 Aug 20;56(2):1902320. doi: 10.1183/13993003.02320-2019. Print 2020 Aug.

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2017
• Primary Completion (Actual): August 16, 2017
• Study Completion (Actual): August 16, 2017

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): August 16, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: pulmonary hypertension; Echocardiography; hypoxia; disease progression; right ventricular function
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 01-8/433A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No