Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-09 @ 11:05 AM
Study NCT ID:
NCT06498505
Status:
RECRUITING
Last Update Posted:
2025-06-13
First Post:
2024-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HighCycle: Effect of Acetazolamide on Pulmonary Artery Pressure in Women Compared to Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000532', 'term': 'Altitude Sickness'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086', 'term': 'Acetazolamide'}], 'ancestors': [{'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2024-07-05', 'studyFirstSubmitQcDate': '2024-07-05', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary artery Pressure (PAP)', 'timeFrame': 'Day 2 at 760 m and Day 2 at 3600 m', 'description': 'Sex-related difference in the altitude-induced change in RV/RA in mmHg assessed by echocardiography between acetazolamide and placebo group.'}], 'secondaryOutcomes': [{'measure': 'Lung comets', 'timeFrame': 'Day 2 at 760 m and Day 2 at 3600 m', 'description': 'Sex-related difference in the altitude-induced change in ultrasound lung comets assessed by echocardiography between acetazolamide and placebo group.'}, {'measure': 'Parameters of right heart function', 'timeFrame': 'Day 2 at 760 m and Day 2 at 3600 m', 'description': 'Sex-related difference in the altitude-induced change in parameters of right heart function assessed by echocardiography between acetazolamide and placebo group.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Women', 'Hypoxia', 'Prevention', 'Acetazolamide', 'Echocardiography'], 'conditions': ['High Altitude']}, 'descriptionModule': {'briefSummary': 'Randomized clinical trial evaluating the effect of acetazolamide on pulmonary artery pressure in women compared to men travelling to 3600 m.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, non-smoking men and women, age 18-44 years, without any diseases and need of regular medication (including oral contraceptives).\n* BMI \\>18 kg/m2 and \\<30 kg/m2\n* Born, raised and currently living at altitudes \\<1000 m\n* Written informed consent\n* Premenopausal women with an eumenorrheic cycle\n\nExclusion Criteria:\n\n* Other types of contraceptvies (hormonal intrauterine device, vaginal ring, subcutaneous injections or implants, among others)\n* Pregnancy or nursing\n* Anaemic (haemoglobin concentration \\<10g/dl)\n* Any altitude trip \\<4 weks before the study\n* Allergy to acetazolamide and other sulfonamides'}, 'identificationModule': {'nctId': 'NCT06498505', 'briefTitle': 'HighCycle: Effect of Acetazolamide on Pulmonary Artery Pressure in Women Compared to Men', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'HighCycle: Effect of Acetazolamide on Pulmonary Artery Pressure in Women Compared to Men. A Randomized, Placebo-Controlled, Double-Blind Parallel Trial.', 'orgStudyIdInfo': {'id': 'HighCycle_PAP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'WOMEN - ACETAZOLAMIDE oral capsule', 'description': 'Acetazolamide 250 mg/day (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', 'interventionNames': ['Drug: Acetazolamide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MEN - ACETAZOLAMIDE oral capsule', 'description': 'Acetazolamide 250 mg/day (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', 'interventionNames': ['Drug: Acetazolamide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'WOMEN - PLACEBO oral capsule', 'description': '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.', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'MEN - PLACEBO oral capsule', 'description': '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.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Acetazolamide', 'type': 'DRUG', 'description': 'Administration of 1x125mg acetazolamide in the morning, 1x125mg in the evening, starting 24 hours before departure to 3600 m.', 'armGroupLabels': ['MEN - ACETAZOLAMIDE oral capsule', 'WOMEN - ACETAZOLAMIDE oral capsule']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administration of equally looking placebo capsules in the morning and in the evening, starting 24 hours before departure to 3600 m.', 'armGroupLabels': ['MEN - PLACEBO oral capsule', 'WOMEN - PLACEBO oral capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '720040', 'city': 'Bishkek', 'state': 'Gorod Bishkek', 'status': 'RECRUITING', 'country': 'Kyrgyzstan', 'contacts': [{'name': 'Talant M Sooronbaev, MD', 'role': 'CONTACT', 'email': 'Sooronbaev@yahoo.com', 'phone': '+996 312 625679'}, {'name': 'Konrad E Bloch, MD', 'role': 'CONTACT', 'email': 'konrad.bloch@usz.ch', 'phone': '+44 255 38 28'}], 'facility': 'National Center for Cardiology and Internal Medicine', 'geoPoint': {'lat': 42.87, 'lon': 74.59}}], 'centralContacts': [{'name': 'Silvia Ulrich, Prof. Dr.', 'role': 'CONTACT', 'email': 'silvia.ulrich@usz.ch', 'phone': '+41442552838'}, {'name': 'Talant Sooronbaev, Prof. Dr.', 'role': 'CONTACT', 'email': 'sooronbaev@yahoo.ru', 'phone': '+996772574567'}], 'overallOfficials': [{'name': 'Silvia Ulrich, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Zurich'}, {'name': 'Talant Sooronbaev, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov', 'class': 'OTHER_GOV'}, {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, {'name': "Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}