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

Uppsala University

Status: Completed

Conditions: Pulmonary Arterial Hypertension

Treatments: Dietary Supplement: Beetroot juice

Study type: Interventional

Funder types: Other

Identifiers

NCT02000856

BEET-PAH

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups, including a placebo group

Nitrate rich beetroot juice

Active Comparator group

Description:

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) .

Treatment:

Dietary Supplement: Beetroot juice

Nitrate depleted beetroot juice

Placebo Comparator group

Description:

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) .

Treatment:

Dietary Supplement: Beetroot juice