Treatment of High Altitude Polycythemia by Acetazolamide
Cuvinte cheie
Abstract
Descriere
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).
Datele
| Ultima verificare: | 12/31/2012 |
| Primul depus: | 01/18/2007 |
| Inscriere estimată trimisă: | 01/18/2007 |
| Prima postare: | 01/21/2007 |
| Ultima actualizare trimisă: | 01/22/2013 |
| Ultima actualizare postată: | 01/23/2013 |
| Data actuală de începere a studiului: | 12/31/2006 |
| Data estimată de finalizare a studiului: | 10/31/2007 |
Stare sau boală
Intervenție / tratament
Drug: acetazolamide
Fază
Grupuri de brațe
| Braţ | Intervenție / tratament |
|---|---|
| Placebo Comparator: acetazolamide acetazolamide 250mg /day oral administration, for 6 months | Drug: acetazolamide |
Criterii de eligibilitate
| Vârste eligibile pentru studiu | 18 Years La 18 Years |
| Sexe eligibile pentru studiu | Male |
| Acceptă voluntari sănătoși | da |
| Criterii | Inclusion Criteria: - patients with Chronic mountain sickness and Hb > 21g/dl Exclusion Criteria: - patients smokers - patients with respiratory or cardiovascular or renal disease |
Rezultat
Măsuri de rezultate primare
1. Hemoglobin concentration [monthly]
2. Hematocrit [monthly]
Măsuri de rezultate secundare
1. Systolic pulmonary arterial pressure [before and after 3 months of treatment]
2. Pulmonary vascular resistance [before and after 3 months of treatment]
3. Arterial oxygen saturation at rest [monthly]
4. Clinical score of Chronic Mountain Sickness [monthly]
5. Quality of lofe score [monthly]
