NCT00424970

Brief Summary

The prevalence of High Altitude Polycythemia (or Chronic Mountain Sickness) is between 8 and 15% in the high altitude regions of South America. There is no pharmacological treatment available. After a first preliminary study in 2003 demonstrating the beneficial effects of acetazolamide in reducing hematocrit in these patients, after 3 weeks of treatment, we want to confirm this effect and implement a treatment protocol of 3 month-duration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

First QC Date

January 19, 2007

Last Update Submit

January 23, 2013

Conditions

High Altitude Polycythemia

Keywords

high altitudehypoxiapulmonary hypertensionpolycythemiahypoventilation

Outcome Measures

Primary Outcomes (2)

  • Hemoglobin concentration

    monthly

  • Hematocrit

    monthly

Secondary Outcomes (5)

  • Systolic pulmonary arterial pressure

    before and after 3 months of treatment

  • Pulmonary vascular resistance

    before and after 3 months of treatment

  • Arterial oxygen saturation at rest

    monthly

  • Clinical score of Chronic Mountain Sickness

    monthly

  • Quality of lofe score

    monthly

Study Arms (1)

acetazolamide

PLACEBO COMPARATOR

acetazolamide 250mg /day oral administration, for 6 months

Drug: acetazolamide

Interventions

acetazolamideDRUG
acetazolamide

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with Chronic mountain sickness and Hb \> 21g/dl

You may not qualify if:

  • patients smokers
  • patients with respiratory or cardiovascular or renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Cayetano Heredia

Lima, 100, Peru

Location

Related Publications (3)

  • Richalet JP, Rivera M, Bouchet P, Chirinos E, Onnen I, Petitjean O, Bienvenu A, Lasne F, Moutereau S, Leon-Velarde F. Acetazolamide: a treatment for chronic mountain sickness. Am J Respir Crit Care Med. 2005 Dec 1;172(11):1427-33. doi: 10.1164/rccm.200505-807OC. Epub 2005 Aug 26.

    PMID: 16126936BACKGROUND

  • Maignan M, Rivera-Ch M, Privat C, Leon-Velarde F, Richalet JP, Pham I. Pulmonary pressure and cardiac function in chronic mountain sickness patients. Chest. 2009 Feb;135(2):499-504. doi: 10.1378/chest.08-1094. Epub 2008 Aug 21.

    PMID: 18719057DERIVED

  • Richalet JP, Rivera-Ch M, Maignan M, Privat C, Pham I, Macarlupu JL, Petitjean O, Leon-Velarde F. Acetazolamide for Monge's disease: efficiency and tolerance of 6-month treatment. Am J Respir Crit Care Med. 2008 Jun 15;177(12):1370-6. doi: 10.1164/rccm.200802-196OC. Epub 2008 Apr 3.

    PMID: 18388356DERIVED

MeSH Terms

Conditions

Altitude SicknessHypoxiaHypertension, PulmonaryPolycythemiaHypoventilation

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsLung DiseasesHypertensionVascular DiseasesCardiovascular DiseasesHematologic DiseasesHemic and Lymphatic DiseasesRespiratory Insufficiency

Intervention Hierarchy (Ancestors)

ThiadiazolesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jean-Paul Richalet, MD, PHD

    ARPE, University Paris 13

    PRINCIPAL INVESTIGATOR

  • Fabiola Leon-Velarde, PHD

    University Cayetano Heredia, Lima, Peru

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 19, 2007

First Posted

January 22, 2007

Study Start

January 1, 2007

Study Completion

November 1, 2007

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

PE(1)