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Treatment of High Altitude Polycythemia by Acetazolamide

Primary Purpose

High Altitude Polycythemia

Status
Completed
Phase
Phase 4
Locations
Peru
Study Type
Interventional
Intervention
acetazolamide
Sponsored by
Association pour la Recherche en Physiologie de l'Environnement
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Altitude Polycythemia focused on measuring high altitude, hypoxia, pulmonary hypertension, polycythemia, hypoventilation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • University Cayetano Heredia

Arms of the Study

Arm 1

Arm Type

Placebo Comparator

Arm Label

acetazolamide

Arm Description

acetazolamide 250mg /day oral administration, for 6 months

Outcomes

Primary Outcome Measures

Hemoglobin concentration
Hematocrit

Secondary Outcome Measures

Systolic pulmonary arterial pressure
Pulmonary vascular resistance
Arterial oxygen saturation at rest
Clinical score of Chronic Mountain Sickness
Quality of lofe score

Full Information

First Posted
January 19, 2007
Last Updated
January 23, 2013
Sponsor
Association pour la Recherche en Physiologie de l'Environnement
Collaborators
University of Paris 13, Universidad Peruana Cayetano Heredia, Legs Poix
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1. Study Identification

Unique Protocol Identification Number
NCT00424970
Brief Title
Treatment of High Altitude Polycythemia by Acetazolamide
Official Title
Hypoventilation and High Altitude Chronic Polycythemia: Acetazolamide as a Possible Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Association pour la Recherche en Physiologie de l'Environnement
Collaborators
University of Paris 13, Universidad Peruana Cayetano Heredia, Legs Poix

4. Oversight

5. Study Description

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.
Detailed Description
Chronic mountain sickness (CMS) is characterized by an excessive number of red cells in the blood of persons living permanently above the altitude of 2,500m. The symptoms of this very incapacitating disease are : headaches, chronic asthenia, digestive troubles, sleep disturbances. The hemoglobin concentration is higher than 21 g/dl of blood. In addition, patients show a pulmonary hypertension of variable degree, as well as a systemic hypertension. This disease affects essentially males, but women are also concerned after menopause. The evolution of the disease is always very dramatic, towards a cardiac failure and cerebral vascular stroke. The prevalence is between 8% and 15% on the Andean Altiplano . No pharmacological treatment is available. A preliminary study was performed (Richalet et al. AJRCCM, 2005) that demonstrated the efficiency of acetazolamide (a carbonic anhydrase inhibitor) in reducing the hematocrit and the erythropoetin concentration,and increasing nocturnal oxygen saturation in patients suffering from CMS, after 3 weeks of treatment. We plan to perform a double-blinded placebo-controlled study to evaluate the efficiency of a 3-month treatment with daily 250 mg acetazolamide to reduce the hematocrit and hemoglobin concentrations and ameliorate the clinical symptoms of 55 patients suffering from CMS and living at high altitude (Cerro de Pasco, Peru).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Altitude Polycythemia
Keywords
high altitude, hypoxia, pulmonary hypertension, polycythemia, hypoventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
acetazolamide
Arm Type
Placebo Comparator
Arm Description
acetazolamide 250mg /day oral administration, for 6 months
Intervention Type
Drug
Intervention Name(s)
acetazolamide
Primary Outcome Measure Information:
Title
Hemoglobin concentration
Time Frame
monthly
Title
Hematocrit
Time Frame
monthly
Secondary Outcome Measure Information:
Title
Systolic pulmonary arterial pressure
Time Frame
before and after 3 months of treatment
Title
Pulmonary vascular resistance
Time Frame
before and after 3 months of treatment
Title
Arterial oxygen saturation at rest
Time Frame
monthly
Title
Clinical score of Chronic Mountain Sickness
Time Frame
monthly
Title
Quality of lofe score
Time Frame
monthly

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with Chronic mountain sickness and Hb > 21g/dl Exclusion Criteria: patients smokers patients with respiratory or cardiovascular or renal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Paul Richalet, MD, PHD
Organizational Affiliation
ARPE, University Paris 13
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fabiola Leon-Velarde, PHD
Organizational Affiliation
University Cayetano Heredia, Lima, Peru
Official's Role
Study Director
Facility Information:
Facility Name
University Cayetano Heredia
City
Lima
ZIP/Postal Code
100
Country
Peru

12. IPD Sharing Statement

Citations:
PubMed Identifier
16126936
Citation
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.
Results Reference
background
PubMed Identifier
18719057
Citation
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.
Results Reference
derived
PubMed Identifier
18388356
Citation
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.
Results Reference
derived

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Treatment of High Altitude Polycythemia by Acetazolamide

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