Treatment of High Altitude Polycythemia by Acetazolamide

Sponsor

Association pour la Recherche en Physiologie de l'Environnement (Other)

Overall Status

Completed

CT.gov ID

NCT00424970

Collaborator

University of Paris 13 (Other), Universidad Peruana Cayetano Heredia (Other), Legs Poix (Other)

Enrollment

Location

Arm

Duration (Months)

5.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
High Altitude Polycythemia	Drug: acetazolamide	Phase 4

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Hypoventilation and High Altitude Chronic Polycythemia: Acetazolamide as a Possible Treatment

Study Start Date :

Jan 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: acetazolamide acetazolamide 250mg /day oral administration, for 6 months	Drug: acetazolamide

Arm

Intervention/Treatment

Placebo Comparator: acetazolamide

acetazolamide 250mg /day oral administration, for 6 months

Drug: acetazolamide

Outcome Measures

Primary Outcome Measures

Hemoglobin concentration [monthly]
Hematocrit [monthly]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Cayetano Heredia	Lima		Peru	100

Sponsors and Collaborators

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

Investigators

Principal Investigator: Jean-Paul Richalet, MD, PHD, ARPE, University Paris 13
Study Director: Fabiola Leon-Velarde, PHD, University Cayetano Heredia, Lima, Peru