|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Association pour la Recherche en Physiologie de l'Environnement |
|---|---|
| Collaborators: |
Université Paris 13, Bobigny, France Universidad Peruana Cayetano Heredia Legs Poix |
| Information provided by: | Association pour la Recherche en Physiologie de l'Environnement |
| ClinicalTrials.gov Identifier: | NCT00424970 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
High Altitude Polycythemia |
Drug: acetazolamide |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Hypoventilation and High Altitude Chronic Polycythemia: Acetazolamide as a Possible Treatment |
| Estimated Enrollment: | 55 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | February 2007 |
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).
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Maria Riveira | mrivera@upch.edu.pe | |
| Contact: Jean-Paul Richalet | richalet@smbh.univ-paris13.fr |
| Peru | |
| 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 |
More Information
| Study ID Numbers: | APCA06, Legs Poix 999 |
| Study First Received: | January 19, 2007 |
| Last Updated: | January 19, 2007 |
| ClinicalTrials.gov Identifier: | NCT00424970 History of Changes |
| Health Authority: | Peru: Ethics Committee |
|
high altitude hypoxia pulmonary hypertension polycythemia hypoventilation |
|
Polycythemia Molecular Mechanisms of Pharmacological Action Hematologic Diseases Physiological Effects of Drugs Diuretics Respiration Disorders Hypoventilation Acetazolamide Enzyme Inhibitors Cardiovascular Agents |
Pharmacologic Actions Signs and Symptoms Carbonic Anhydrase Inhibitors Respiratory Insufficiency Respiratory Tract Diseases Natriuretic Agents Therapeutic Uses Signs and Symptoms, Respiratory Central Nervous System Agents Anticonvulsants |