BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension

Conditions
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Pulmonary Arterial Hypertension

Intervention / Treatment
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* Dietary Supplement: Beetroot juice


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nitrate rich beetroot juice<br>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) . | Dietary Supplement: Beetroot juice<br> <br> |
| Placebo Comparator: Nitrate depleted beetroot juice<br>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) . | Dietary Supplement: Beetroot juice<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in VO2 submax and or VO2 max |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6MWT |  | 7 days | 
| Change in WHO functional class |  | 7 days | 
| Change in echocardiographic parameters | 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 | 7 days | 
| Change in exhaled NO |  | 7 days | 
| Change in systemic bloodpressure |  | 7 days | 
| Change in metabolic pathways involved in nitric oxide production and regulation | Change in the following biochemical variables will be calculated; ADMA, SDMA, Arginine, Citrulline, Ornithine, uric acid, nitrate, nitrite | 7 days | 
| Change in NT-pro-BNP |  | 7 days |