High Altitude Polycythemia Clinical Trial
Official title:
Hypoventilation and High Altitude Chronic Polycythemia: Acetazolamide as a Possible Treatment
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.
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).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04557995 -
Clinical Efficacy of Erythropheresis in High Altitude Polycythemia
|
N/A | |
| Not yet recruiting |
NCT06082583 -
The Efficacy of Combination of Traditional Tibetan and Remote Ischemic Conditioning on High Altitude Polycythemia
|
Phase 2/Phase 3 |