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Treatment of High Altitude Polycythemia by Acetazolamide

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ClinicalTrials.gov Identifier: NCT00424970
Recruitment Status : Completed
First Posted : January 22, 2007
Last Update Posted : January 24, 2013
Sponsor:
Collaborators:
University of Paris 13
Universidad Peruana Cayetano Heredia
Legs Poix
Information provided by:
Association pour la Recherche en Physiologie de l'Environnement

Study Description
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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.

Condition or disease Intervention/treatment Phase
High Altitude Polycythemia Drug: acetazolamide Phase 4

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).


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Hypoventilation and High Altitude Chronic Polycythemia: Acetazolamide as a Possible Treatment
Study Start Date : January 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: acetazolamide
acetazolamide 250mg /day oral administration, for 6 months
 Drug: acetazolamide


Outcome Measures
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Primary Outcome Measures :
  1. Hemoglobin concentration [ Time Frame: monthly ]
  2. Hematocrit [ Time Frame: monthly ]

Secondary Outcome Measures :
  1. Systolic pulmonary arterial pressure [ Time Frame: before and after 3 months of treatment ]
  2. Pulmonary vascular resistance [ Time Frame: before and after 3 months of treatment ]
  3. Arterial oxygen saturation at rest [ Time Frame: monthly ]
  4. Clinical score of Chronic Mountain Sickness [ Time Frame: monthly ]
  5. Quality of lofe score [ Time Frame: monthly ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424970


Locations
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Peru
University Cayetano Heredia
Lima, Peru, 100
Sponsors and Collaborators
Association pour la Recherche en Physiologie de l'Environnement
University of Paris 13
Universidad Peruana Cayetano Heredia
Legs Poix
Investigators
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Principal Investigator: Jean-Paul Richalet, MD, PHD ARPE, University Paris 13
Study Director: Fabiola Leon-Velarde, PHD University Cayetano Heredia, Lima, Peru
More Information
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Publications:

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

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ClinicalTrials.gov Identifier: NCT00424970     History of Changes
Other Study ID Numbers: APCA06
Legs Poix 999
First Posted: January 22, 2007    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013
Keywords provided by Association pour la Recherche en Physiologie de l'Environnement:
high altitude
hypoxia
pulmonary hypertension
polycythemia
hypoventilation
Additional relevant MeSH terms:
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Altitude Sickness
Hypoventilation
Polycythemia
Hematologic Diseases
Respiration Disorders
Respiratory Tract Diseases
Respiratory Insufficiency
Signs and Symptoms, Respiratory
Signs and Symptoms
 Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs