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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02000856
Recruitment Status : Completed
First Posted : December 4, 2013
Last Update Posted : March 27, 2018
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Uppsala University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Dietary Supplement: Beetroot juice Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension
Study Start Date : November 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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) .
 Dietary Supplement: Beetroot juice
Placebo Comparator: 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) .
 Dietary Supplement: Beetroot juice


Outcome Measures
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Primary Outcome Measures :
  1. Change in VO2 submax and or VO2 max [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Change in 6MWT [ Time Frame: 7 days ]
  2. Change in WHO functional class [ Time Frame: 7 days ]
  3. Change in echocardiographic parameters [ Time Frame: 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

  4. Change in exhaled NO [ Time Frame: 7 days ]
  5. Change in systemic bloodpressure [ Time Frame: 7 days ]
  6. Change in metabolic pathways involved in nitric oxide production and regulation [ Time Frame: 7 days ]
    Change in the following biochemical variables will be calculated; ADMA, SDMA, Arginine, Citrulline, Ornithine, uric acid, nitrate, nitrite

  7. Change in NT-pro-BNP [ Time Frame: 7 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000856


Locations
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Sweden
Uppsala University Hospital
Uppsala, Sweden
Sponsors and Collaborators
Uppsala University
Karolinska Institutet
Investigators
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Principal Investigator: Gerhard Wikström, MD, PhD Uppsala University and Uppsala University Hospital
More Information
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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT02000856    
Other Study ID Numbers: BEET-PAH
First Posted: December 4, 2013    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases