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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

Tracking Information
First Submitted Date  ICMJE January 19, 2007
First Posted Date  ICMJE January 22, 2007
Last Update Posted Date January 24, 2013
Study Start Date  ICMJE January 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2013)
  • Hemoglobin concentration [ Time Frame: monthly ]
  • Hematocrit [ Time Frame: monthly ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 19, 2007)
  • Hemoglobin concentration after 3 months of treatment
  • Hematocrit after 3 months of treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2013)
  • Systolic pulmonary arterial pressure [ Time Frame: before and after 3 months of treatment ]
  • Pulmonary vascular resistance [ Time Frame: before and after 3 months of treatment ]
  • Arterial oxygen saturation at rest [ Time Frame: monthly ]
  • Clinical score of Chronic Mountain Sickness [ Time Frame: monthly ]
  • Quality of lofe score [ Time Frame: monthly ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2007)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of High Altitude Polycythemia by Acetazolamide
Official Title  ICMJE Hypoventilation and High Altitude Chronic Polycythemia: Acetazolamide as a Possible Treatment
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE High Altitude Polycythemia
Intervention  ICMJE Drug: acetazolamide
Study Arms  ICMJE Placebo Comparator: acetazolamide
acetazolamide 250mg /day oral administration, for 6 months
Intervention: Drug: acetazolamide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 19, 2007)
55
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • patients smokers
  • patients with respiratory or cardiovascular or renal disease
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Peru
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00424970
Other Study ID Numbers  ICMJE APCA06
Legs Poix 999
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Association pour la Recherche en Physiologie de l'Environnement
Collaborators  ICMJE
  • University of Paris 13
  • Universidad Peruana Cayetano Heredia
  • Legs Poix
Investigators  ICMJE
Principal Investigator: Jean-Paul Richalet, MD, PHD ARPE, University Paris 13
Study Director: Fabiola Leon-Velarde, PHD University Cayetano Heredia, Lima, Peru
PRS Account Association pour la Recherche en Physiologie de l'Environnement
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP