[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602050":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":46,"locations":55,"responsibleParty":73,"collaborators":75,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":30,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":30,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":104,"overallStatus":58,"whyStopped":30,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Centre d'Expertise sur l'Altitude EXALT","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Acetazolamide","EXPERIMENTAL","Acetazolamide 250 mg\u002Fday (capsules @125 mg; 1 in the morning, 1 in the evening), orally. Medication starts 24 hours before ascent to 3600 m until the morning after the second night at 3600 m",[13],"Drug: Acetazolamide",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo (capsules identically looking as acetazolamide capsules; 1 in the morning, 1 in the evening), orally. Medication starts 24 hours before ascent to 3600 m until the morning after the second night at 3600 m.",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Administration of 1x125mg acetazolamide in the morning, 1x125mg in the evening, starting 24 hours before departure to 3600 m.",[9],[26],"Diamox®",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Administration of equally looking placebo capsules in the morning and in the evening, starting 24 hours before departure to 3600 m.",[15],null,[32,36,40,44],{"name":33,"affiliation":34,"role":35},"Michael Furian, Prof. Dr.","University of Zurich","STUDY_CHAIR",{"name":37,"affiliation":38,"role":39},"Talant M Sooronbaev, Prof. Dr.","National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan","STUDY_DIRECTOR",{"name":41,"affiliation":42,"role":43},"Paul Robach, PhD","EXALT (Centre d'Expertise sur l'Altitude), Grenoble, France","PRINCIPAL_INVESTIGATOR",{"name":45,"affiliation":42,"role":43},"Benoit Champigneulle, MD, PhD",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":30,"email":51},"Benoit Champigneulle, MD PhD","CONTACT","+33476769288","BChampigneulle@chu-grenoble.fr",{"name":41,"role":49,"phone":53,"phoneExt":30,"email":54},"+33667053919","paul.robach@ensm.sports.gouv.fr",[56],{"facility":57,"status":58,"city":59,"state":30,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"National Center for Cardiology and Internal Medicine","RECRUITING","Bishkek","720040","Kyrgyzstan","KG",{"type":64,"coordinates":65},"Point",[66,67],74.59,42.87,{"lat":67,"lon":66},[70],{"name":37,"role":49,"phone":71,"phoneExt":30,"email":72},"+996 312 625679","sooronbaev@yahoo.com",{"type":74,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[76,79],{"name":77,"class":78},"National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov","OTHER_GOV",{"name":34,"class":6},"100602050","phase-4-highcycle-study-acetazolamide-high-altitude-and-plasma-volume-100602050",false,"NCT07118462","HighCycle Study: Acetazolamide, High Altitude and Plasma Volume","HighCycle Study: Effect of Acetazolamide on Plasma Volume During Acute Exposure to High Altitude in Women and Men","Inclusion Criteria:\n\n* Healthy, non-smoking men and women, age 18-44 years, without any disease and need of regular medication (including oral contraceptives).\n* BMI \\>18 kg\u002Fm2 and \\\u003C30 kg\u002Fm2.\n* Born, raised and currently living at altitudes \\\u003C1000 m.\n* Written informed consent.\n* Premenopausal women with an eumenorrheic cycle.\n\nExclusion Criteria:\n\n* Other types of contraceptvies (contraceptives (hormonal intrauterine device, vaginal ring, subcutaneous injections or implants, among others).\n* Pregnancy or nursing\n* Anaemic (haemoglobin concentration \\\u003C10g\u002Fdl).\n* Any altitude trip \\\u003C4 weks before the study.\n* Allergy to acetazolamide and other sulfonamides.",true,"ALL","18 Years","44 Years",{"count":92,"type":93},270,"ESTIMATED","INTERVENTIONAL",[96],"PHASE4","Each year, millions of people living at low altitude (\\\u003C 1,000 m) travel to high altitude (≥ 2,500 m) for work, tourism, or sports activities. These individuals are exposed to hypobaric hypoxia, which can trigger acute mountain sickness (AMS)-the most common form of altitude-related illness. Therefore, understanding the physiological responses to hypoxia that allow acclimatization, as well as the pathophysiology of acute mountain sickness, is of primary importance.\n\nThe hematological response to high-altitude exposure initially includes a reduction in plasma volume (PV), leading to an early increase in hemoglobin concentration within the first 24 hours. In contrast, an increase in hemoglobin mass requires several weeks at high altitude. Recent well-controlled physiological studies conducted in hypobaric chambers have demonstrated that this hypoxia-induced PV contraction results from fluid redistribution from the intravascular to the extravascular compartment, rather than from water loss due to increased diuresis.\n\nProphylaxis of AMS is primarily based on the administration of 250 mg\u002Fday of acetazolamide (ACZ), a carbonic anhydrase inhibitor with a mild diuretic effect. Acetazolamide induces metabolic acidosis, which stimulates ventilation and thereby improves oxygenation. The effect of prophylactic ACZ use during high-altitude exposure on PV in lowlanders remains unknown: it is unclear whether ACZ leads to a greater reduction in PV due to its diuretic effect, or to a smaller hypoxia-induced PV contraction as a result of improved oxygenation induced by increased ventilation.",[99,100,101,102,103],"High Altitude Effects","High Altitude Hypoxia","Acute Mountain Sickness (AMS)","Plasma Volume","Women",[105,106,107,108,109,110],"acetazolamide","plasma volume","acute mountain sickness","high altitude","hypoxia","women","2025-08-11",{"date":113,"type":114},"2025-08-12","ACTUAL",{"date":116,"type":114},"2024-07-15",{"date":118,"type":93},"2025-12-31",{"name":5,"class":6},1]