Chronic Mountain Sickness, Systemic Vascular Function (CMS)
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|ClinicalTrials.gov Identifier: NCT01182792|
Recruitment Status : Active, not recruiting
First Posted : August 17, 2010
Last Update Posted : June 16, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Mountain Sickness Chronic||Dietary Supplement: Vitamin C and E Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Chronic Hypoxemia and Systemic Vascular Function|
|Study Start Date :||October 2008|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||December 2021|
Dietary Supplement: Vitamin C and E
1 month, 1g Vitamin C and 400 IE Vitamin E or Acute, 1g Vitamin C (in the offspring)
|Placebo Comparator: Control||
Dietary Supplement: Placebo
1 month Placebo
- Endothelial Function [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01182792
|Istituto Boliviano de Biologia de Altura, Universitad S. Andres|
|La Paz, Bolivia|
|University Hospital Lausanne, Botnar Center for Extreme Medicine|
|Lausanne, Vaud, Switzerland, 1011|