Right Ventricular Function During Exercise in Highlanders/Lowlanders

Right Ventricular Function During Exercise in Highlanders With Pulmonary Hypertension Compared to Highlanders Without Pulmonary Hypertension and Lowlanders

The purpose of the current study is to evaluate the right ventricular function during graded cycling on an ergometer by transthoracic echocardiography 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 pumonary 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 (PAP) during exercise	Difference in change of tricuspid pressure gradient during exercise between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders, measured by transthoracic echocardiography during graded cycling on an ergometer	Day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac output (CO) during exercise	Difference in change of cardiac output during exercise between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders, measured by transthoracic echocardiography during graded cycling on an ergometer	Day 2
PAP/CO slope during exercise	Difference in change of PAP/CO slope during exercise between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders, measured by transthoracic echocardiography during graded cycling on an ergometer	Day 2
Oxygen saturation	Difference in change of oxygen saturation during exercise between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders, measured by transthoracic echocardiography during graded cycling on an ergometer	Day 2

Collaborators and Investigators

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

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 22, 2017
• First Submitted That Met QC Criteria: May 22, 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: exercise; echocardiography; pulmonary hypertension; hypoxia; right ventricular function
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 01-8/433B

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