Treatment of High Altitude Polycythemia by Acetazolamide

NCT ID: NCT00424970

Last Updated: 2013-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2007-11-30

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 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).

Conditions

High Altitude Polycythemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

acetazolamide

acetazolamide 250mg /day oral administration, for 6 months

Group Type: PLACEBO_COMPARATOR

acetazolamide

Intervention Type: DRUG

Interventions

acetazolamide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• patients smokers
• patients with respiratory or cardiovascular or renal disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Paris 13

OTHER

Sponsor Role: collaborator

Universidad Peruana Cayetano Heredia

OTHER

Sponsor Role: collaborator

Legs Poix

UNKNOWN

Sponsor Role: collaborator

Association pour la Recherche en Physiologie de l'Environnement

OTHER

Sponsor Role: lead

Principal Investigators

Jean-Paul Richalet, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

ARPE, University Paris 13

Fabiola Leon-Velarde, PHD

Role: STUDY_DIRECTOR

University Cayetano Heredia, Lima, Peru

Locations

University Cayetano Heredia

Lima, , Peru

Countries

Peru

References

Richalet JP, Rivera M, Bouchet P, Chirinos E, Onnen I, Petitjean O, Bienvenu A, Lasne F, Moutereau S, Leon-Velarde F. Acetazolamide: a treatment for chronic mountain sickness. Am J Respir Crit Care Med. 2005 Dec 1;172(11):1427-33. doi: 10.1164/rccm.200505-807OC. Epub 2005 Aug 26.

Reference Type: BACKGROUND

PMID: 16126936 (View on PubMed)

Maignan M, Rivera-Ch M, Privat C, Leon-Velarde F, Richalet JP, Pham I. Pulmonary pressure and cardiac function in chronic mountain sickness patients. Chest. 2009 Feb;135(2):499-504. doi: 10.1378/chest.08-1094. Epub 2008 Aug 21.

Reference Type: DERIVED

PMID: 18719057 (View on PubMed)

Richalet JP, Rivera-Ch M, Maignan M, Privat C, Pham I, Macarlupu JL, Petitjean O, Leon-Velarde F. Acetazolamide for Monge's disease: efficiency and tolerance of 6-month treatment. Am J Respir Crit Care Med. 2008 Jun 15;177(12):1370-6. doi: 10.1164/rccm.200802-196OC. Epub 2008 Apr 3.

Reference Type: DERIVED

PMID: 18388356 (View on PubMed)

Other Identifiers

Legs Poix 999

Identifier Type: -

Identifier Source: secondary_id

APCA06

Identifier Type: -

Identifier Source: org_study_id