Right Ventricular Function During Exercise in Highlanders/Lowlanders

Sponsor

University of Zurich (Other)

Overall Status

Completed

CT.gov ID

NCT03165032

Collaborator

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

173

Enrollment

Location

2.8

Actual Duration (Months)

62.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
High Altitude Pulmonary Hypertension

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

173 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

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

pulmonary artery pressure (PAP) during exercise [Day 2]
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

Secondary Outcome Measures

cardiac output (CO) during exercise [Day 2]
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
PAP/CO slope during exercise [Day 2]
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
Oxygen saturation [Day 2]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

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