Treatment of High Altitude Polycythemia by Acetazolamide

Phase 4

Completed

• Conditions: High Altitude Polycythemia
• Interventions: Drug: acetazolamide

• Registration Number: NCT00424970
• Lead Sponsor: Association pour la Recherche en Physiologie de l'Environnement

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).

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-19
• Study First Submitted QC: 2007-01-19
• Study First Posted: 2007-01-22
• Study Completion: 2007-11
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-23
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 55

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acetazolamide	acetazolamide	acetazolamide 250mg /day oral administration, for 6 months

Primary Outcome Measures

Name	Time	Method
Hemoglobin concentration	monthly
Hematocrit	monthly

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Cayetano Heredia; 🇵🇪 Lima, Peru