Treatment of High Altitude Polycythemia by Acetazolamide
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Hypoventilation and High Altitude Chronic Polycythemia: Acetazolamide as a Possible Treatment|
- Hemoglobin concentration [ Time Frame: monthly ]
- Hematocrit [ Time Frame: monthly ]
- Systolic pulmonary arterial pressure [ Time Frame: before and after 3 months of treatment ]
- Pulmonary vascular resistance [ Time Frame: before and after 3 months of treatment ]
- Arterial oxygen saturation at rest [ Time Frame: monthly ]
- Clinical score of Chronic Mountain Sickness [ Time Frame: monthly ]
- Quality of lofe score [ Time Frame: monthly ]
|Study Start Date:||January 2007|
|Study Completion Date:||November 2007|
Placebo Comparator: acetazolamide
acetazolamide 250mg /day oral administration, for 6 months
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424970
|University Cayetano Heredia|
|Lima, Peru, 100|
|Principal Investigator:||Jean-Paul Richalet, MD, PHD||ARPE, University Paris 13|
|Study Director:||Fabiola Leon-Velarde, PHD||University Cayetano Heredia, Lima, Peru|