Trial record 5 of 538 for:    PAH

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

This study has been completed.
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT02000856
First received: November 19, 2013
Last updated: December 3, 2015
Last verified: December 2015
  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 ]

Enrollment: 15
Study Start Date: November 2013
Study Completion Date: February 2015
Primary Completion Date: February 2015 (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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02000856

Locations
Sweden
Uppsala University Hospital
Uppsala, Sweden
Sponsors and Collaborators
Uppsala University
Karolinska Institutet
Investigators
Principal Investigator: Gerhard Wikström, MD, PhD Uppsala University and Uppsala University Hospital
  More Information

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: December 3, 2015
Health Authority: Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on August 22, 2016