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Completed

NCT Number: NCT02000856

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

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.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala University Hospital

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beetroot juice

Dietary Supplement

Primary outcomes

  1. Change in VO2 submax and or VO2 max

    Time frame: 7 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Karolinska Institutet

Registry information

Acronym: BEET-PAH

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 4, 2013
Registry last updated
Mar 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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