Treatment of Chronic Mountain Sickness
Cuvinte cheie
Abstract
Descriere
About 100 million individuals reside at high altitude (>2500m) worldwide, with the largest populations of highlanders being found in South America (Andean), central Asia (Tibetan and Sherpa) and East Africa (Ethiopian). Despite unique adaptations to hypoxia in these populations, chronic mountain sickness (CMS) is a clinical syndrome which is observed in 5-33% of individuals residing permanently at high altitude.Several pharmacological approaches have been proposed in the treatment of EE and CMS. However, few studies show sufficient clinical evidence for safety and efficacy in CMS treatment and most highlanders with CMS remain untreated. The present project aims to better characterize chronic hypoxic responses in highlanders and to evaluate the interest of acetazolamide and statins as potential treatments for chronic mountain sickness.
Datele
| Ultima verificare: | 02/29/2020 |
| Primul depus: | 01/28/2020 |
| Inscriere estimată trimisă: | 01/29/2020 |
| Prima postare: | 01/30/2020 |
| Ultima actualizare trimisă: | 02/29/2020 |
| Ultima actualizare postată: | 03/02/2020 |
| Data actuală de începere a studiului: | 02/14/2020 |
| Data estimată de finalizare primară: | 08/29/2020 |
| Data estimată de finalizare a studiului: | 08/29/2020 |
Stare sau boală
Intervenție / tratament
Drug: Acetazolamide
Drug: Atorvastatin
Drug: Placebo
Fază
Grupuri de brațe
| Braţ | Intervenție / tratament |
|---|---|
| Experimental: Acetazolamide Oral acetazolamide (250 mg/day) intake for 6 months | Drug: Acetazolamide Daily acetazolamide pill intake |
| Experimental: Atorvastatin Oral atorvastatin (40 mg/day) intake for 6 months | Drug: Atorvastatin Daily atorvastatin pill intake |
| Placebo Comparator: Placebo Oral placebo pill (daily) intake for 6 months | Drug: Placebo Daily placebo pill intake |
Criterii de eligibilitate
| Vârste eligibile pentru studiu | 18 Years La 18 Years |
| Sexe eligibile pentru studiu | Male |
| Acceptă voluntari sănătoși | da |
| Criterii | Inclusion Criteria: - Male - Age between 18 and 55 yrs - Body mass index <30kg/m² - Born at >3500 m, living for >3 years at the local high altitude - No diagnosis of cardiorespiratory, metabolic or neurological diseases - No drug intake - No smoker - Chronic mountain sickness score ≥6 Exclusion Criteria: - Diagnosis of cardiorespiratory, metabolic and neurological diseases - Systolic > 130 mmHg and/or diastolic > 85 mmHg blood pressure - Drug intake - Smoker - Chronic mountain sickness score <6 |
Rezultat
Măsuri de rezultate primare
1. Change in hematocrit [Change from before to after 6 months of treatment]
Măsuri de rezultate secundare
1. Chronic mountain sickness score [Change from before to after 6 months of treatment]
2. Macrovascular reactivity [Change from before to after 6 months of treatment]
3. Microvascular reactivity [Change from before to after 6 months of treatment]
4. Hemoglobin mass [Change from before to after 6 months of treatment]
5. Pulmonary arterial pressure [Change from before to after 6 months of treatment]
6. Blood pressure [Change from before to after 6 months of treatment]
7. Sleep recording [Change from before to after 6 months of treatment]
