Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424970
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2007-01-19
Brief Title:
Treatment of High Altitude Polycythemia by Acetazolamide
Sponsor:
Association pour la Recherche en Physiologie de lEnvironnement
Organization:
Association pour la Recherche en Physiologie de lEnvironnement
Study Overview
Official Title:
Hypoventilation and High Altitude Chronic Polycythemia Acetazolamide as a Possible Treatment
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 2500m The symptoms of this very incapacitating disease are headaches chronic asthenia digestive troubles sleep disturbances The hemoglobin concentration is higher than 21 gdl 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 concentrationand 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
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 concentrationand 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Legs Poix 999 | None | None | None |