Chronic Mountain Sickness, Systemic Vascular Function (CMS)
Primary Purpose
Mountain Sickness, Chronic
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Vitamin C and E
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Mountain Sickness focused on measuring Endothelial Function, Chronic Hypoxia, Oxidative Stress
Eligibility Criteria
Inclusion Criteria:
- Patients with Chronic Mountain Sickness and their offspring
Exclusion Criteria:
- Smoking
- Lung disease
- Arterial Hypertension
Sites / Locations
- Istituto Boliviano de Biologia de Altura, Universitad S. Andres
- University Hospital Lausanne, Botnar Center for Extreme Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Antioxidant
Control
Arm Description
Outcomes
Primary Outcome Measures
Endothelial Function
Secondary Outcome Measures
Full Information
NCT ID
NCT01182792
First Posted
August 16, 2010
Last Updated
June 15, 2020
Sponsor
University of Lausanne Hospitals
Collaborators
Instituto Boliviano de Biologia de Altura, Universitad Major de S. Andres, La Paz, Bolivia
1. Study Identification
Unique Protocol Identification Number
NCT01182792
Brief Title
Chronic Mountain Sickness, Systemic Vascular Function
Acronym
CMS
Official Title
Chronic Hypoxemia and Systemic Vascular Function
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals
Collaborators
Instituto Boliviano de Biologia de Altura, Universitad Major de S. Andres, La Paz, Bolivia
4. Oversight
5. Study Description
Brief Summary
Diseases associated with chronic hypoxemia like chronic obstructive pulmonary disease (COPD) or emphysema, represent major medical and socio-economical problems and one of the leading cause of morbidity and mortality in the western countries. Recently, is has been shown that cardiovascular (CV) diseases contribute highly to the morbidity and mortality of these patients. Furthermore, increasing evidence suggest that systemic vascular dysfunction play a central role in the mediation of the increased CV risk in patients with COPD. However the underlying mechanisms of vascular dysfunction in these patients are incompletely understood. Chronic mountain sickness (CMS) is characterized by chronic hypoxemia related at least in part to hypoventilation; it affects relatively young adults, and may therefore allow to study the effects of chronic hypoxemia. The investigators therefore will assess systemic vascular function and test the hypothesis that increased oxidative stress is responsible for this dysfunction. Since polyglobulia is a hallmark of chronic hypoxemia and has been suggested to affect vascular function, the investigators will test the effects of hemodilution on vascular function. Then, the investigators will test the effects of acute oxygen application and 1 month antioxidative dietary supplement on vascular function.
Preliminary data suggest that offspring of CMS patients may display pulmonary and systemic vascular dysfunction. Antioxidant administration is know to improve vascular function. We will test the acute effect of Vitamin C in this setting.
Finally, since there is considerable inter-individual variability of pulmonary artery pressure among CMS patients and the presence of a patent foramen ovale (PFO)is increased in clinical conditions associated with pulmonary hypertension and hypoxemia, we will assess the prevalence of PFO in healthy high altitude dwellers and in CMS patients and its effects on pulmonary artery pressure at rest and during mild exercise.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mountain Sickness, Chronic
Keywords
Endothelial Function, Chronic Hypoxia, Oxidative Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Antioxidant
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin C and E
Intervention Description
1 month, 1g Vitamin C and 400 IE Vitamin E or Acute, 1g Vitamin C (in the offspring)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
1 month Placebo
Primary Outcome Measure Information:
Title
Endothelial Function
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with Chronic Mountain Sickness and their offspring
Exclusion Criteria:
Smoking
Lung disease
Arterial Hypertension
Facility Information:
Facility Name
Istituto Boliviano de Biologia de Altura, Universitad S. Andres
City
La Paz
Country
Bolivia
Facility Name
University Hospital Lausanne, Botnar Center for Extreme Medicine
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
35398201
Citation
Bailey DM, Culcasi M, Filipponi T, Brugniaux JV, Stacey BS, Marley CJ, Soria R, Rimoldi SF, Cerny D, Rexhaj E, Pratali L, Salmon CS, Jauregui CM, Villena M, Villafuerte F, Rockenbauer A, Pietri S, Scherrer U, Sartori C. EPR spectroscopic evidence of iron-catalysed free radical formation in chronic mountain sickness: Dietary causes and vascular consequences. Free Radic Biol Med. 2022 May 1;184:99-113. doi: 10.1016/j.freeradbiomed.2022.03.028. Epub 2022 Apr 6.
Results Reference
derived
PubMed Identifier
26540612
Citation
Rexhaj E, Rimoldi SF, Pratali L, Brenner R, Andries D, Soria R, Salinas C, Villena M, Romero C, Allemann Y, Lovis A, Heinzer R, Sartori C, Scherrer U. Sleep-Disordered Breathing and Vascular Function in Patients With Chronic Mountain Sickness and Healthy High-Altitude Dwellers. Chest. 2016 Apr;149(4):991-8. doi: 10.1378/chest.15-1450. Epub 2016 Jan 12.
Results Reference
derived
PubMed Identifier
25375664
Citation
Brenner R, Pratali L, Rimoldi SF, Murillo Jauregui CX, Soria R, Rexhaj E, Salinas Salmon C, Villena M, Romero C, Sartori C, Allemann Y, Scherrer U. Exaggerated pulmonary hypertension and right ventricular dysfunction in high-altitude dwellers with patent foramen ovale. Chest. 2015 Apr;147(4):1072-1079. doi: 10.1378/chest.14-1353.
Results Reference
derived
PubMed Identifier
24269266
Citation
Pratali L, Allemann Y, Rimoldi SF, Faita F, Hutter D, Rexhaj E, Brenner R, Bailey DM, Sartori C, Salmon CS, Villena M, Scherrer U, Picano E, Sicari R. RV contractility and exercise-induced pulmonary hypertension in chronic mountain sickness: a stress echocardiographic and tissue Doppler imaging study. JACC Cardiovasc Imaging. 2013 Dec;6(12):1287-97. doi: 10.1016/j.jcmg.2013.08.007. Epub 2013 Oct 23.
Results Reference
derived
PubMed Identifier
22922469
Citation
Bailey DM, Rimoldi SF, Rexhaj E, Pratali L, Salinas Salmon C, Villena M, McEneny J, Young IS, Nicod P, Allemann Y, Scherrer U, Sartori C. Oxidative-nitrosative stress and systemic vascular function in highlanders with and without exaggerated hypoxemia. Chest. 2013 Feb 1;143(2):444-451. doi: 10.1378/chest.12-0728.
Results Reference
derived
PubMed Identifier
21885723
Citation
Pratali L, Rimoldi SF, Rexhaj E, Hutter D, Faita F, Salmon CS, Villena M, Sicari R, Picano E, Allemann Y, Scherrer U, Sartori C. Exercise induces rapid interstitial lung water accumulation in patients with chronic mountain sickness. Chest. 2012 Apr;141(4):953-958. doi: 10.1378/chest.11-0084. Epub 2011 Sep 1.
Results Reference
derived
PubMed Identifier
21700688
Citation
Rimoldi SF, Rexhaj E, Pratali L, Bailey DM, Hutter D, Faita F, Salinas Salmon C, Villena M, Nicod P, Allemann Y, Scherrer U, Sartori C. Systemic vascular dysfunction in patients with chronic mountain sickness. Chest. 2012 Jan;141(1):139-146. doi: 10.1378/chest.11-0342. Epub 2011 Jun 23.
Results Reference
derived
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Chronic Mountain Sickness, Systemic Vascular Function
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