NCT03165032

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

May 24, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2017

Completed
Last Updated

August 16, 2019

Status Verified

August 1, 2019

Enrollment Period

3 months

First QC Date

May 22, 2017

Last Update Submit

August 15, 2019

Conditions

Keywords

exerciseechocardiographyright ventricular functionpulmonary hypertensionhypoxia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • cardiac output (CO) during exercise

    Day 2

  • PAP/CO slope during exercise

    Day 2

  • Oxygen saturation

    Day 2

Study Arms (3)

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.

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Center for Cardiology and Internal Medicine

Bishkek, 720040, Kyrgyzstan

Location

MeSH Terms

Conditions

Pulmonary edema of mountaineersMotor ActivityHypertension, PulmonaryHypoxia

Condition Hierarchy (Ancestors)

BehaviorLung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

May 22, 2017

First Posted

May 24, 2017

Study Start

May 24, 2017

Primary Completion

August 16, 2017

Study Completion

August 16, 2017

Last Updated

August 16, 2019

Record last verified: 2019-08

Locations