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Treatment of High Altitude Polycythemia by Acetazolamide
This study is not yet open for participant recruitment.
Verified by Association pour la Recherche en Physiologie de l'Environnement, January 2007
First Received: January 19, 2007   No Changes Posted
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

Resource links provided by NLM:


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
Lima, Peru, 100
Sponsors and Collaborators
Association pour la Recherche en Physiologie de l'Environnement
Université Paris 13, Bobigny, France
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:
Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
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

Keywords provided by Association pour la Recherche en Physiologie de l'Environnement:
high altitude
hypoxia
pulmonary hypertension
polycythemia
hypoventilation

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010