Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-02 @ 11:25 AM
Study NCT ID:
NCT02000856
Status:
COMPLETED
Last Update Posted:
2018-03-27
First Post:
2013-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-24', 'studyFirstSubmitDate': '2013-11-19', 'studyFirstSubmitQcDate': '2013-11-26', 'lastUpdatePostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in VO2 submax and or VO2 max', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'Change in 6MWT', 'timeFrame': '7 days'}, {'measure': 'Change in WHO functional class', 'timeFrame': '7 days'}, {'measure': 'Change in echocardiographic parameters', 'timeFrame': '7 days', 'description': 'Change in; pulmonary artery systolic pressure (PASP), ventricular diastolic function, systolic right and left ventricular function, right and left atrial/ventricular dimensions will be calculated'}, {'measure': 'Change in exhaled NO', 'timeFrame': '7 days'}, {'measure': 'Change in systemic bloodpressure', 'timeFrame': '7 days'}, {'measure': 'Change in metabolic pathways involved in nitric oxide production and regulation', 'timeFrame': '7 days', 'description': 'Change in the following biochemical variables will be calculated; ADMA, SDMA, Arginine, Citrulline, Ornithine, uric acid, nitrate, nitrite'}, {'measure': 'Change in NT-pro-BNP', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pulmonary Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'The study is a single center randomised, double-blind, placebo-controlled crossover study to assess the effects of beetroot juice in patients with pulmonary arterial hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PAH (pulmonary arterial hypertension)\n* WHO functional class II-III\n\nExclusion Criteria:\n\n* WHO functional class I or IV\n* pregnancy\n* known intolerance or allergy to beetroot\n* treatment with Allopurinol\n* treatment with Iloprost (inhaled)\n* systolic bloodpressure \\< 95 mmHg\n* diabetes mellitus type 2'}, 'identificationModule': {'nctId': 'NCT02000856', 'acronym': 'BEET-PAH', 'briefTitle': 'BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension', 'orgStudyIdInfo': {'id': 'BEET-PAH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nitrate rich beetroot juice', 'description': 'Eligible subjects will be randomised, in a double-blind crossover design, to receive treatment with either nitrate rich beetroot juice (70 ml containing approximately 8 mmol nitrate - active comparator) or nitrate depleted beetroot juice (70 ml - placebo) twice daily for 7 days (treatment period 1) followed by a 7 day washout period followed by treatment twice daily with the active comparator or placebo depending on initial treatment for another 7 days (treatment period 2) .', 'interventionNames': ['Dietary Supplement: Beetroot juice']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Nitrate depleted beetroot juice', 'description': 'Eligible subjects will be randomised, in a double-blind crossover design, to receive treatment with either nitrate rich beetroot juice (70 ml containing approximately 8 mmol nitrate - active comparator) or nitrate depleted beetroot juice (70 ml - placebo)twice daily for 7 days (treatment period 1) followed by a 7 day washout period followed by treatment twice daily with the active comparator or placebo depending on initial treatment for another 7 days (treatment period 2) .', 'interventionNames': ['Dietary Supplement: Beetroot juice']}], 'interventions': [{'name': 'Beetroot juice', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Nitrate depleted beetroot juice', 'Nitrate rich beetroot juice']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Gerhard Wikström, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University and Uppsala University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}