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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02000856 |
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Date of registration:
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19/11/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension
BEET-PAH |
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Scientific title:
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BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension |
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Date of first enrolment:
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November 2013 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02000856 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Gerhard Wikström, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Uppsala University and Uppsala University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- PAH (pulmonary arterial hypertension)
- WHO functional class II-III
Exclusion Criteria:
- WHO functional class I or IV
- pregnancy
- known intolerance or allergy to beetroot
- treatment with Allopurinol
- treatment with Iloprost (inhaled)
- systolic bloodpressure < 95 mmHg
- diabetes mellitus type 2
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Dietary Supplement: Beetroot juice
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Primary Outcome(s)
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Change in VO2 submax and or VO2 max
[Time Frame: 7 days]
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Secondary Outcome(s)
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Change in 6MWT
[Time Frame: 7 days]
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Change in echocardiographic parameters
[Time Frame: 7 days]
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Change in WHO functional class
[Time Frame: 7 days]
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Change in systemic bloodpressure
[Time Frame: 7 days]
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Change in metabolic pathways involved in nitric oxide production and regulation
[Time Frame: 7 days]
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Change in NT-pro-BNP
[Time Frame: 7 days]
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Change in exhaled NO
[Time Frame: 7 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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