Right Ventricular Function During Exercise in Highlanders/Lowlanders

High Altitude Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03165032
• Other study ID #: 01-8/433B
• Status: Completed
• Start date: May 24, 2017
• Est. completion date: August 16, 2017

Study information

• Verified date: August 2019
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: August 16, 2017
• Est. primary completion date: August 16, 2017
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Altitude Sickness
• High Altitude Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary

Locations

Country	Name	City	State
Kyrgyzstan	National Center for Cardiology and Internal Medicine	Bishkek

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	National Center of Cardiology and Internal Medicine, Kyrgyzstan

Country where clinical trial is conducted

Kyrgyzstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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