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Treatment of High Altitude Polycythemia by Acetazolamide

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00424970
Enrollment
55
Registered
2007-01-22
Start date
2007-01-31
Completion date
2007-11-30
Last updated
2013-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Altitude Polycythemia

Keywords

high altitude, hypoxia, pulmonary hypertension, polycythemia, hypoventilation

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).

Interventions

DRUGacetazolamide

Sponsors

University of Paris 13
CollaboratorOTHER
Universidad Peruana Cayetano Heredia
CollaboratorOTHER
Legs Poix
CollaboratorUNKNOWN
Association pour la Recherche en Physiologie de l'Environnement
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Hemoglobin concentrationmonthly
Hematocritmonthly

Secondary

MeasureTime frame
Arterial oxygen saturation at restmonthly
Systolic pulmonary arterial pressurebefore and after 3 months of treatment
Quality of lofe scoremonthly
Clinical score of Chronic Mountain Sicknessmonthly
Pulmonary vascular resistancebefore and after 3 months of treatment

Countries

Peru

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026