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NCT02000856 Clinical Trial

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

Pulmonary Arterial Hypertension Clinical Trial

— BEET-PAH  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02000856
Other study ID # BEET-PAH
Secondary ID
Status Completed
Phase N/A
First received November 19, 2013
Last updated March 24, 2018
Start date November 2013
Est. completion date February 2015

Study information
Verified date March 2018
Source Uppsala University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Beetroot juice

Locations
Country Name City State
Sweden Uppsala University Hospital Uppsala

Sponsors (2)
Lead Sponsor Collaborator
Uppsala University Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in VO2 submax and or VO2 max 7 days
Secondary Change in 6MWT 7 days
Secondary Change in WHO functional class 7 days
Secondary 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
Secondary Change in exhaled NO 7 days
Secondary Change in systemic bloodpressure 7 days
Secondary 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
Secondary Change in NT-pro-BNP 7 days
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