Skip to main content
OpenTrials
Completed

NCT Number: NCT00424970

Treatment of High Altitude Polycythemia by Acetazolamide

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

High Altitude Polycythemia Altitude Sickness Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypertension Hypertension, Pulmonary Hypoventilation Hypoxia Lung Diseases Pathological Conditions, Signs and Symptoms Polycythemia Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

University Cayetano Heredia

Lima, 100, Peru

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Acetazolamide

Drug

Primary outcomes

  1. Hemoglobin concentration

    Time frame: monthly

  2. Hematocrit

    Time frame: monthly

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Association pour la Recherche en Physiologie de l'Environnement

Other

Collaborators

  • Legs Poix
  • Universidad Peruana Cayetano Heredia
  • University of Paris 13

Registry information

Official study title

Hypoventilation and High Altitude Chronic Polycythemia: Acetazolamide as a Possible Treatment

Important dates

Study start
2007
Study completion
2007
First posted
Jan 22, 2007
Registry last updated
Jan 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.