Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-03 @ 2:36 AM
Study NCT ID:
NCT03167034
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2017-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Acetazolamide on Right Ventricular Function During Exercise in Patients With Respiratory Disease at Altitude
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D004646', 'term': 'Emphysema'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-12', 'studyFirstSubmitDate': '2017-05-23', 'studyFirstSubmitQcDate': '2017-05-23', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pulmonary artery pressure during exercise', 'timeFrame': 'Day 2 at 3200m', 'description': 'Difference in change of tricuspid pressure gradient during exercise between acetazolamide and placebo group at altitude, measured by transthoracic echocardiography during graded cycling on an ergometer'}], 'secondaryOutcomes': [{'measure': 'pulmonary artery pressure during exercise', 'timeFrame': 'Day 2 at 760 m and 3200 m', 'description': 'Difference in altitude-induced change of tricuspid pressure gradient during exercise between acetazolamide and placebo group, measured by transthoracic echocardiography during graded cycling on an ergometer'}, {'measure': 'cardiac output during exercise', 'timeFrame': 'Day 2 at 3200m', 'description': 'Difference in change of cardiac output during exercise between acetazolamide and placebo group at altitude, measured by transthoracic echocardiography during graded cycling on an ergometer'}, {'measure': 'cardiac output during exercise', 'timeFrame': 'Day 2 at 760 m and 3200 m', 'description': 'Difference in altitude-induced change of cardiac output during exercise between acetazolamide and placebo group, measured by transthoracic echocardiography during graded cycling on an ergometer'}, {'measure': 'PAP/CO slope during exercise', 'timeFrame': 'Day 2 at 3200m', 'description': 'Difference in change of PAP/CO slope during exercise between acetazolamide and placebo group at altitude, measured by transthoracic echocardiography during graded cycling on an ergometer'}, {'measure': 'PAP/CO slope during exercise', 'timeFrame': 'Day 2 at 760 m and 3200 m', 'description': 'Difference in altitude-induced change of PAP/CO slope during exercise between acetazolamide and placebo group, measured by transthoracic echocardiography during graded cycling on an ergometer'}, {'measure': 'Oxygen saturation', 'timeFrame': 'Day 2 and 3200 m', 'description': 'Difference in altitude-induced change during exercise of oxygen saturation between acetazolamide and placebo group, measured by pulse oximeter'}, {'measure': 'Oxygen saturation', 'timeFrame': 'Day 2 at 760 m and 3200 m', 'description': 'Difference in change of oxygen saturation during exercise between acetazolamide and placebo group, measured by pulse oximeter'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise', 'echocardiography', 'right ventricular function', 'obstructive airway disease', 'emphysema', 'acetazolamide', 'altitude'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'This trial will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on right ventricular function during exercise at acute altitude exposure in patients with COPD.', 'detailedDescription': 'This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide (375 mg per day) vs. placebo on right ventricular function during exercise in lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo) will be administered 24 hours before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m.\n\nRight ventricular function will be assessed during graded cycling on an ergometer by transthoracic echocardiography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients, age 18-75 yrs.\n* COPD diagnosed according to GOLD, FEV1 40-80% predicted, SpO2 ≥92% at 750 m.\n* Born, raised and currently living at low altitude (\\<800m).\n* Written informed consent.\n\nExclusion Criteria:\n\n* COPD exacerbation, very severe COPD with hypoxemia at low altitude (FEV1/FVC \\<0.7, FEV1 \\<40% predicted, oxygen saturation on room air \\<92% at 750 m).\n* Comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke; OSA; pneumothorax in the last 2 months.\n* Internal, neurologic, rheumatologic or psychiatric disease including current heavy smoking (\\>20 cigarettes per day)\n* Known renal failure or allergy to acetazolamide and other sulfonamides'}, 'identificationModule': {'nctId': 'NCT03167034', 'briefTitle': 'Effect of Acetazolamide on Right Ventricular Function During Exercise in Patients With Respiratory Disease at Altitude', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Effect of Acetazolamide on Right Ventricular Function During Exercise in Patients With Chronic Obstructive Pulmonary Disease at Altitude. A Randomized, Placebo-controlled, Double-blind Parallel Trial.', 'orgStudyIdInfo': {'id': '2017-00137F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ACETAZOLAMIDE oral capsule', 'description': 'Acetazolamide 375mg/day (capsule @125 mg: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3200m until the morning after the second night at 3200m', 'interventionNames': ['Drug: ACETAZOLAMIDE oral capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLACEBO oral capsule', 'description': 'Placebo (capsules identically looking as acetazolamide capsules: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3200m until the morning after the second night at 3200m.', 'interventionNames': ['Drug: Placebo oral capsule']}], 'interventions': [{'name': 'ACETAZOLAMIDE oral capsule', 'type': 'DRUG', 'description': 'Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m', 'armGroupLabels': ['ACETAZOLAMIDE oral capsule']}, {'name': 'Placebo oral capsule', 'type': 'DRUG', 'description': 'Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m', 'armGroupLabels': ['PLACEBO oral capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '720040', 'city': 'Bishkek', 'country': 'Kyrgyzstan', 'facility': 'National Center for Cardiology and Internal Medicine', 'geoPoint': {'lat': 42.87, 'lon': 74.59}}], 'overallOfficials': [{'name': 'Silvia Ulrich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}, {'name': 'Talant M Sooronbaev', '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'}], 'responsibleParty': {'type': 'SPONSOR'}}}}