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

Not Applicable

Completed

• Conditions: Pulmonary Arterial Hypertension

• 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

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-19
• Study First Submitted QC: 2013-11-26
• Study First Posted: 2013-12-04
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-24
• Last Update Posted: 2018-03-27

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

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