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Chronic Mountain Sickness, Systemic Vascular Function

Chronic Hypoxemia and Systemic Vascular Function

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01182792
Acronym
CMS
Enrollment
50
Registered
2010-08-17
Start date
2008-10-31
Completion date
2021-12-31
Last updated
2020-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic, Mountain Sickness

Keywords

Endothelial Function, Chronic Hypoxia, Oxidative Stress

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.

Interventions

DIETARY_SUPPLEMENTVitamin C and E

1 month, 1g Vitamin C and 400 IE Vitamin E or Acute, 1g Vitamin C (in the offspring)

DIETARY_SUPPLEMENTPlacebo

1 month Placebo

Sponsors

Instituto Boliviano de Biologia de Altura
CollaboratorUNKNOWN
Universitad Major de S. Andres, La Paz, Bolivia
CollaboratorUNKNOWN
University of Lausanne Hospitals
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patients with Chronic Mountain Sickness and their offspring

Exclusion criteria

* Smoking * Lung disease * Arterial Hypertension

Design outcomes

Primary

MeasureTime frame
Endothelial Function1 month

Countries

Bolivia, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026