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

Primary Purpose

Pulmonary Arterial Hypertension

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Beetroot juice
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Uppsala University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nitrate rich beetroot juice

Nitrate depleted beetroot juice

Arm 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) .

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) .

Outcomes

Primary Outcome Measures

Change in VO2 submax and or VO2 max

Secondary Outcome Measures

Change in 6MWT
Change in WHO functional class
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
Change in exhaled NO
Change in systemic bloodpressure
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
Change in NT-pro-BNP

Full Information

First Posted
November 19, 2013
Last Updated
March 24, 2018
Sponsor
Uppsala University
Collaborators
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02000856
Brief Title
BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension
Acronym
BEET-PAH
Official Title
BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nitrate rich beetroot juice
Arm Type
Active Comparator
Arm 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) .
Arm Title
Nitrate depleted beetroot juice
Arm Type
Placebo Comparator
Arm 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) .
Intervention Type
Dietary Supplement
Intervention Name(s)
Beetroot juice
Primary Outcome Measure Information:
Title
Change in VO2 submax and or VO2 max
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Change in 6MWT
Time Frame
7 days
Title
Change in WHO functional class
Time Frame
7 days
Title
Change in echocardiographic parameters
Description
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
Time Frame
7 days
Title
Change in exhaled NO
Time Frame
7 days
Title
Change in systemic bloodpressure
Time Frame
7 days
Title
Change in metabolic pathways involved in nitric oxide production and regulation
Description
Change in the following biochemical variables will be calculated; ADMA, SDMA, Arginine, Citrulline, Ornithine, uric acid, nitrate, nitrite
Time Frame
7 days
Title
Change in NT-pro-BNP
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Wikström, MD, PhD
Organizational Affiliation
Uppsala University and Uppsala University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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