Treatment of High Altitude Polycythemia by Acetazolamide - Full Text View

Sponsor:	Association pour la Recherche en Physiologie de l'Environnement
Collaborators:	University of Paris 13 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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Hypoventilation and High Altitude Chronic Polycythemia: Acetazolamide as a Possible Treatment

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Acetazolamide Acetazolamide sodium

U.S. FDA Resources

Further study details as provided by Association pour la Recherche en Physiologie de l'Environnement:

Primary Outcome Measures:

Hemoglobin concentration after 3 months of treatment
Hematocrit after 3 months of treatment

Secondary Outcome Measures:

Systolic pulmonary arterial pressure after 3 months of treatment
Pulmonary vascular resistance after 3 months of treatment
Arterial oxygen saturation at rest after 3 months of treatment
Clinical score of Chronic Mountain Sickness after 3 months of treatment
Quality of lofe score after 3 months of treatment

Estimated Enrollment:	55
Study Start Date:	January 2007
Estimated Study Completion Date:	February 2007

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).

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

patients smokers
patients with respiratory or cardiovascular or renal disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424970

Contacts

Contact: Maria Riveira		mrivera@upch.edu.pe
Contact: Jean-Paul Richalet		richalet@smbh.univ-paris13.fr

Locations

Peru
University Cayetano Heredia	Not yet recruiting
Lima, Peru, 100
Contact: Maria Riveira mrivera@upch.edu.pe
Principal Investigator: Jean-Paul Richalet, MD, PHD

Sponsors and Collaborators

Association pour la Recherche en Physiologie de l'Environnement

University of Paris 13

Universidad Peruana Cayetano Heredia

Legs Poix

Investigators

Principal Investigator:	Jean-Paul Richalet, MD, PHD	ARPE, University Paris 13
Study Director:	Fabiola Leon-Velarde, PHD	University Cayetano Heredia, Lima, Peru

More Information

Publications:

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. Epub 2005 Aug 26.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Richalet JP, Rivera-Ch M, Maignan M, Privat C, Pham I, Macarlupu JL, Petitjean O, León-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. Epub 2008 Apr 3.

ClinicalTrials.gov Identifier:	NCT00424970 History of Changes
Other Study ID Numbers:	APCA06, Legs Poix 999
Study First Received:	January 19, 2007
Last Updated:	January 19, 2007
Health Authority:	Peru: Ethics Committee

Keywords provided by Association pour la Recherche en Physiologie de l'Environnement:

high altitude
hypoxia
pulmonary hypertension
polycythemia
hypoventilation

Additional relevant MeSH terms:

Polycythemia
Hypoventilation
Hematologic Diseases
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Acetazolamide
Anticonvulsants

Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012