High Altitude Pulmonary HypertensionNCT03165656
Right Ventricular Function at Rest in Highlanders/Lowlanders
An observational study of High Altitude Pulmonary Hypertension, run by University of Zurich at 1 site in Kyrgyzstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- High Altitude Pulmonary Hypertension
- How many people
- 173 participants
- Where
- 1 siteKyrgyzstan
- Study dates
- 24 May 2017to 16 Aug 2017
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Highlanders with high altitude pulmonary 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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Kyrgyzstan1 site
National Center for Cardiology and Internal Medicine
Bishkek, 720040
About this study
Official title: Right Ventricular Function at Rest in Highlanders With Pulmonary Hypertension Compared to Highlanders Without Pulmonary Hypertension and Lowlanders
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.
- Conditions
- High Altitude Pulmonary Hypertension
- Keywords
- Echocardiography, right ventricular function, pulmonary hypertension, disease progression, hypoxia
- Medical subject headings
- Pulmonary edema of mountaineers, Hypertension, Pulmonary, Disease Progression, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary artery pressure
Difference between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders in tricuspid pressure gradient, measured by transthoracic echocardiography
Measured: Day 2
Secondary outcomes (5)
cardiac output
Difference between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders in cardiac output, measured by transthoracic echocardiography
Measured: Day 2
right heart dimensions
Difference of right heart dimensions between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders, measured by transthoracic echocardiography
Measured: Day 2
Right heart function
Differences of right heart function between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders, measured by transthoracic echocardiography (TAPSE)
Measured: Day 2
stroke volume
Difference between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders in stroke volume, measured by transthoracic echocardiography
Measured: Day 2
volumes
Difference of volumes between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders, measured by transthoracic echocardiography
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start24 May 2017
- Primary completion16 Aug 2017
- Study completion16 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Altitude Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Responsible party
- Principal investigator, Silvia Ulrich Somaini, University of Zurich
- Investigators
- Talant M Sooronbaev, MD, Study chair, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165656
- Sponsor's protocol ID
- 01-8/433A
- Status last verified
- Aug 2019
- First submitted
- 23 May 2017
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32430415
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Ventricular Function at Rest in Highlanders With Pulmonary Hypertension Compared to Highlanders Without Pulmonary Hypertension and Lowlanders
- ClinicalTrials.gov ID
- NCT03165656
- Acronym / sponsor ID
- 01-8/433A
- Conditions
- High Altitude Pulmonary Hypertension
- Keywords
- Echocardiography, right ventricular function, pulmonary hypertension, disease progression, hypoxia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Study start
- 24 May 2017 (actual)
- Primary completion
- 16 Aug 2017 (actual)
- Study completion
- 16 Aug 2017 (actual)
- First posted
- 24 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Highlanders with high altitude pulmonary 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulmonary artery pressure
Time frame: Day 2
Difference between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders in tricuspid pressure gradient, measured by transthoracic echocardiography
5 secondary outcomes
cardiac output
Time frame: Day 2
right heart dimensions
Time frame: Day 2
Right heart function
Time frame: Day 2
stroke volume
Time frame: Day 2
volumes
Time frame: Day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- Derived from this study: PubMed 32430415Gosens 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.
- Individual participant dataSharing planned: Undecided
Related trials for High Altitude Pulmonary Hypertension
Not yet recruiting
Assessment of Lung Function (Lufu) at Sea Level LA vs. High Altitude HA in Healthy Individuals
Healthy, Healthy Adult
Not yet recruiting
Assessment of Total Pulmonary Resistance sPAP/CO Between Sea Level LA vs. High Altitude HA After Re-ascent in Healthy Individuals
High Altitude, Healthy
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Assessment of Total Pulmonary Resistance sPAP/CO Between Sea Level LA vs. High Altitude HA After Re-ascent in Patients With Pulmonary Arterial Hypertension PAH
Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease
Not yet recruiting
Assessment of Total Pulmonary Resistance sPAP/CO Between High Altitude HA vs. Sea Level LA in Healthy Individuals H
High Altitude, Healthy Adult
Not yet recruiting
Assessment of Six-minute Walking Distance 6MWD Between High Altitude HA vs. Sea Level LA in Patients With Pulmonary Arterial Hypertension PAH
Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Talant M Sooronbaev, MD study chair
National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Altitude Pulmonary Hypertension, run by University of Zurich at 1 site in Kyrgyzstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kyrgyzstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary artery pressure (time frame: Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03165656, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2019.