Right Ventricular Function at Rest in Highlanders/Lowlanders

NCT03165656 — Completed, 173 participants, University of Zurich

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT03165656
Status	Completed
Study type	Observational
Enrollment	173 (Actual)
Sponsor	University of Zurich (Other); collaborators: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Conditions	High Altitude Pulmonary Hypertension
Dates	start 2017-05-24, primary completion 2017-08-16, completion 2017-08-16, first posted 2017-05-24, last updated 2019-08-16
Locations	1 site in Kyrgyzstan

-Summary

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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
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 outcomes

Pulmonary artery pressure [Day 2]: Difference between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders in tricuspid pressure gradient, measured by transthoracic echocardiography

Secondary outcomes

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

+Eligibility

Sex: All, ages: 16 Years to any

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

+Locations (1)

Facility	City	Country	Status
National Center for Cardiology and Internal Medicine	Bishkek	Kyrgyzstan

+Publications

Results publication: 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. PMID 32430415

+Investigators

Talant M Sooronbaev, MD, Study chair, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

My Notes

Public

To Read Reading Read