Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01182792
Other study ID # CMS
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT00092937 - Use of Busulfan as Conditioning Agent for a Second Stem Cell Transplant Phase 1
Completed NCT02638467 - Allogeneic Stem Cell Transplantation in Chronic Myeloid Leukemia Failing TKIs Therapy Phase 2
Completed NCT00878085 - Functional Magnetic Resonance Imaging (fMRI) and Robot-Assisted Practice of Activities of Daily Living Phase 1
Terminated NCT00842413 - Investigating the Role of the Premotor Cortex in Higher Cognitive Functions N/A
Recruiting NCT03251352 - TKI Discontinuation in CML Patients of China
Completed NCT01117870 - Assess the Effectiveness of Pulse RadioFrequency in Patients With Chronic Lumbar Radicular Pain N/A
Active, not recruiting NCT03899584 - High Doses of 4-aminopyridine in Clinically Complete Chronic Spinal Cord Injury Patients. Phase 3
Terminated NCT03759184 - Human IL-15 (rhIL-15) and Obinutuzumab for Relapsed and Refractory Chronic Lymphocyte Leukemia Phase 1
Suspended NCT02577120 - Wound Healing Endpoint and Recurrence Phase 4
Terminated NCT05330598 - Evaluation of the Safety and Clinical Performance of the Connected Catheter Study N/A
Recruiting NCT04170582 - Patient Registry for Patients With Chronic Subdural Hematoma
Completed NCT00077922 - Anti-Tac(Fv)-PE38 (LMB-2) to Treat Chronic Lymphocytic Leukemia Phase 2
Not yet recruiting NCT03964766 - Pulpectomy of Primary Molars With Rotary Instrumentation Versus Manual Instrumentation N/A