BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension
Not Applicable
Completed
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Dietary Supplement: Beetroot juice
- Registration Number
- NCT02000856
- Lead Sponsor
- Uppsala University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Nitrate depleted beetroot juice Beetroot juice 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) . Nitrate rich beetroot juice Beetroot juice 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) .
- Primary Outcome Measures
Name Time Method Change in VO2 submax and or VO2 max 7 days
- Secondary Outcome Measures
Name Time Method Change in WHO functional class 7 days Change in 6MWT 7 days Change in NT-pro-BNP 7 days Change in systemic bloodpressure 7 days Change in echocardiographic parameters 7 days 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
Change in exhaled NO 7 days Change in metabolic pathways involved in nitric oxide production and regulation 7 days Change in the following biochemical variables will be calculated; ADMA, SDMA, Arginine, Citrulline, Ornithine, uric acid, nitrate, nitrite
Trial Locations
- Locations (1)
Uppsala University Hospital
🇸🇪Uppsala, Sweden