NCT01182792

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2010

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

12.7 years

First QC Date

August 16, 2010

Last Update Submit

June 15, 2020

Conditions

Mountain SicknessChronic

Keywords

Endothelial FunctionChronic HypoxiaOxidative Stress

Outcome Measures

Primary Outcomes (1)

  • Endothelial Function

    1 month

Study Arms (2)

Antioxidant

EXPERIMENTAL
Dietary Supplement: Vitamin C and E

Control

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Vitamin C and EDIETARY_SUPPLEMENT

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

Antioxidant
PlaceboDIETARY_SUPPLEMENT

1 month Placebo

Control

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Chronic Mountain Sickness and their offspring

You may not qualify if:

  • Smoking
  • Lung disease
  • Arterial Hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istituto Boliviano de Biologia de Altura, Universitad S. Andres

La Paz, Bolivia

Location

University Hospital Lausanne, Botnar Center for Extreme Medicine

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (7)

  • 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.

    PMID: 35398201DERIVED

  • 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.

    PMID: 26540612DERIVED

  • 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.

    PMID: 25375664DERIVED

  • 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.

    PMID: 24269266DERIVED

  • 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.

    PMID: 22922469DERIVED

  • 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.

    PMID: 21885723DERIVED

  • 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.

    PMID: 21700688DERIVED

MeSH Terms

Conditions

Altitude SicknessBronchiolitis Obliterans Syndrome

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

August 16, 2010

First Posted

August 17, 2010

Study Start

October 1, 2008

Primary Completion

June 1, 2021

Study Completion

December 1, 2021

Last Updated

June 16, 2020

Record last verified: 2020-06

Locations

CH(1)BO(1)