|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03172429 |
|
Date of registration:
|
23/05/2017 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Cerebral Tissue Oxygenation in Highlanders/Lowlanders
|
|
Scientific title:
|
Cerebral Tissue Oxygenation in Highlanders With Pulmonary Hypertension Compared to Highlanders Without Pulmonary Hypertension and Lowlanders |
|
Date of first enrolment:
|
May 24, 2017 |
|
Target sample size:
|
79 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03172429 |
|
Study type:
|
Observational [Patient Registry] |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Kyrgyzstan
| | | | | | | |
|
Contacts
|
|
Name:
|
Talant M Sooronbaev, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
NCCIM |
| | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
16 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
High Altitude Pulmonary Hypertension
|
|
Primary Outcome(s)
|
|
Changes in cerebral tissue oxygenation
[Time Frame: Year 2012 to 2017]
|
|
Secondary Outcome(s)
|
|
Arterial oxygen saturation
[Time Frame: Year 2012 to 2017]
|
|
Changes in cerebrovascular response to hyperoxia
[Time Frame: Year 2012 to 2017]
|
|
Changes in cerebrovascular response to hypocapnia
[Time Frame: Year 2012 to 2017]
|
|
Secondary ID(s)
|
|
01-8/433C
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|