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

NCT ID: NCT02000856

Last Updated: 2018-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-02-28

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.

Conditions

Pulmonary Arterial Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Nitrate rich 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) .

Group Type: ACTIVE_COMPARATOR

Beetroot juice

Intervention Type: DIETARY_SUPPLEMENT

Nitrate depleted 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) .

Group Type: PLACEBO_COMPARATOR

Beetroot juice

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Beetroot juice

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerhard Wikström, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University and Uppsala University Hospital

Locations

Uppsala University Hospital

Uppsala, , Sweden

Countries

Sweden

Other Identifiers

BEET-PAH

Identifier Type: -

Identifier Source: org_study_id