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

This study is currently recruiting participants.
Verified November 2013 by Uppsala University
Sponsor:
Collaborator:
Department of Physiology and Pharmacology Karolinska Institute Stockholm
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT02000856
First received: November 19, 2013
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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 Intervention
Pulmonary Arterial Hypertension
Dietary Supplement: Beetroot juice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Change in VO2 submax and or VO2 max [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in 6MWT [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Change in WHO functional class [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Change in echocardiographic parameters [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Change in systemic bloodpressure [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Change in metabolic pathways involved in nitric oxide production and regulation [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Change in the following biochemical variables will be calculated; ADMA, SDMA, Arginine, Citrulline, Ornithine, uric acid, nitrate, nitrite

  • Change in NT-pro-BNP [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 4 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 4 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02000856

Contacts
Contact: Gerhard Wikström, MD, PhD gerhard.wikstrom@medsci.uu.se

Locations
Sweden
Uppsala University Hospital Recruiting
Uppsala, Sweden
Principal Investigator: Gerhard Wikström, MD, PhD         
Sponsors and Collaborators
Uppsala University
Department of Physiology and Pharmacology Karolinska Institute Stockholm
Investigators
Principal Investigator: Gerhard Wikström, MD, PhD Uppsala University and Uppsala University Hospital
  More Information

No publications provided

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT02000856     History of Changes
Other Study ID Numbers: BEET-PAH
Study First Received: November 19, 2013
Last Updated: November 26, 2013
Health Authority: Sweden: Uppsala Regional Ethical Review Board (Sweden)

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014