Chronic Mountain Sickness, Systemic Vascular Function

Chronic Clinical Trial

— CMS  

Official title:

Chronic Hypoxemia and Systemic Vascular Function

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01182792
• Other study ID #: CMS
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2008
• Est. completion date: December 2021

Study information

• Verified date: June 2020
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• Patients with Chronic Mountain Sickness and their offspring

Exclusion Criteria:

• Smoking

• Lung disease

• Arterial Hypertension

Related Conditions & MeSH terms

• Altitude Sickness
• Chronic
• Mountain Sickness

Intervention

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
1 month Placebo

Locations

Country	Name	City	State
Bolivia	Istituto Boliviano de Biologia de Altura, Universitad S. Andres	La Paz
Switzerland	University Hospital Lausanne, Botnar Center for Extreme Medicine	Lausanne	Vaud

Sponsors (3)

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

Countries where clinical trial is conducted

Bolivia,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Function		1 month