Treatment of High Altitude Polycythemia by Acetazolamide

High Altitude Polycythemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00424970
• Other study ID #: APCA06
• Secondary ID: Legs Poix 999
• Status: Completed
• Phase: Phase 4
• First received: January 19, 2007
• Last updated: January 23, 2013
• Start date: January 2007
• Est. completion date: November 2007

Study information

• Verified date: January 2013
• Source: Association pour la Recherche en Physiologie de l'Environnement
• Contact: n/a
• Is FDA regulated: No
• Health authority: Peru: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients with Chronic mountain sickness and Hb > 21g/dl

Exclusion Criteria:

• patients smokers

• patients with respiratory or cardiovascular or renal disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Altitude Sickness
• High Altitude Polycythemia
• Hypoventilation
• Polycythemia

Intervention

Drug:
• acetazolamide

Locations

Country	Name	City	State
Peru	University Cayetano Heredia	Lima

Sponsors (4)

Lead Sponsor	Collaborator
Association pour la Recherche en Physiologie de l'Environnement	Legs Poix, Universidad Peruana Cayetano Heredia, University of Paris 13

Country where clinical trial is conducted

Peru, 

References & Publications (1)

Richalet JP, Rivera M, Bouchet P, Chirinos E, Onnen I, Petitjean O, Bienvenu A, Lasne F, Moutereau S, León-Velarde F. Acetazolamide: a treatment for chronic mountain sickness. Am J Respir Crit Care Med. 2005 Dec 1;172(11):1427-33. Epub 2005 Aug 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin concentration		monthly
Primary	Hematocrit		monthly
Secondary	Systolic pulmonary arterial pressure		before and after 3 months of treatment
Secondary	Pulmonary vascular resistance		before and after 3 months of treatment
Secondary	Arterial oxygen saturation at rest		monthly
Secondary	Clinical score of Chronic Mountain Sickness		monthly
Secondary	Quality of lofe score		monthly