Treatment of High Altitude Polycythemia by Acetazolamide

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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High Altitude Polycythemia

Intervention / Treatment
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* Drug: acetazolamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with Chronic mountain sickness and Hb > 21g/dl Exclusion Criteria: patients smokers patients with respiratory or cardiovascular or renal disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: acetazolamide<br>acetazolamide 250mg /day oral administration, for 6 months | Drug: acetazolamide<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin concentration |  | monthly | 
| Hematocrit |  | monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high altitude, hypoxia, pulmonary hypertension, polycythemia, hypoventilation