BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension
BEET-PAH
1 other identifier
interventional
15
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 19, 2013
CompletedFirst Posted
Study publicly available on registry
December 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedMarch 27, 2018
March 1, 2018
1.3 years
November 19, 2013
March 24, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in VO2 submax and or VO2 max
7 days
Secondary Outcomes (7)
Change in 6MWT
7 days
Change in WHO functional class
7 days
Change in echocardiographic parameters
7 days
Change in exhaled NO
7 days
Change in systemic bloodpressure
7 days
- +2 more secondary outcomes
Study Arms (2)
Nitrate rich beetroot juice
ACTIVE COMPARATOREligible 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) .
Nitrate depleted beetroot juice
PLACEBO COMPARATOREligible 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) .
Interventions
Eligibility Criteria
You may qualify if:
- PAH (pulmonary arterial hypertension)
- WHO functional class II-III
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uppsala Universitylead
- Karolinska Institutetcollaborator
Study Sites (1)
Uppsala University Hospital
Uppsala, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerhard Wikström, MD, PhD
Uppsala University and Uppsala University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2013
First Posted
December 4, 2013
Study Start
November 1, 2013
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
March 27, 2018
Record last verified: 2018-03