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Acute Dietary Nitrate in Dilated Cardiomyopathy

Primary Purpose

Cardiomyopathy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dietary nitrate
Placebo
Sponsored by
Royal College of Surgeons, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cardiomyopathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

Inclusion Criteria:

  • Clinically stable,
  • Confirmed non-ischemic, dilated cardiomyopathy

Exclusion Criteria:

  • Active musculo-skeletal conditions
  • Ischemic heart disease
  • Pulmonary hypertension
  • COPD
  • Taking vasodilators
  • Diabetes mellitus

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Nitrate rich beetroot juice

    Nitrate depleted placebo beetroot juice

    Arm Description

    Concentrated, beetroot juice is a rich source of dietary nitrate.

    Placebo beetroot juice is identical to active beetroot juice in every way except nitrate content.

    Outcomes

    Primary Outcome Measures

    Change between incremental shuttle walk test distance pre and post juice

    Secondary Outcome Measures

    Clinic blood pressure
    Plasma nitrate
    Dyspnoea using self report, validated Borg scale
    Oxygen saturation using pulse oximetry
    Plasma nitrite

    Full Information

    First Posted
    January 7, 2015
    Last Updated
    June 10, 2015
    Sponsor
    Royal College of Surgeons, Ireland
    Collaborators
    University College Dublin, Connolly Hospital Blanchardstown
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02471417
    Brief Title
    Acute Dietary Nitrate in Dilated Cardiomyopathy
    Official Title
    Dietary Nitrate Supplementation in Dilated Cardiomyopathy: An Acute, Double-blind, Randomized, Placebo-controlled, Crossover Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Royal College of Surgeons, Ireland
    Collaborators
    University College Dublin, Connolly Hospital Blanchardstown

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Acute consumption of dietary nitrate (as beetroot juice) has been shown to improve exercise capacity in athletes, healthy adults and subjects with both peripheral vascular disease or COPD. Many patients with dilated cardiomyopathy have reduced exercise capacity, The investigators hypothesized that acute nitrate consumption might increase incremental shuttle walk test (ISWT) distance in dilated cardiomyopathy subjects compared to a placebo beetroot juice.
    Detailed Description
    Acute consumption of dietary nitrate (as beetroot juice) has been shown to improve exercise capacity in athletes, healthy adults and subjects with both peripheral vascular disease or COPD. Many patients with dilated cardiomyopathy have reduced exercise capacity, The investigators hypothesized that acute nitrate consumption might increase incremental shuttle walk test (ISWT) distance in dilated cardiomyopathy subjects compared to a placebo beetroot juice. This study is a randomized, double-blind placebo-controlled, crossover trial. Resting blood pressure, phlebotomy and ISWT will be performed. Following completion, each subject is randomized to consume beetroot juice or placebo. 3 hours later, the same assessments are repeated by the same people. After a 7d washout, the entire protocol is repeated with the crossover beverage.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiomyopathy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nitrate rich beetroot juice
    Arm Type
    Experimental
    Arm Description
    Concentrated, beetroot juice is a rich source of dietary nitrate.
    Arm Title
    Nitrate depleted placebo beetroot juice
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo beetroot juice is identical to active beetroot juice in every way except nitrate content.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Dietary nitrate
    Other Intervention Name(s)
    Beetroot juice
    Intervention Description
    140ml of nitrate rich beetroot juice provides 12.9mmol nitrate and will be on a single occasion by the study subjects.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Nitrate depleted beetroot juice
    Intervention Description
    140ml of nitrate depleted beetroot juice provides 0.5mmol nitrate and will be on a single occasion by the study subjects.
    Primary Outcome Measure Information:
    Title
    Change between incremental shuttle walk test distance pre and post juice
    Time Frame
    Day 1 and day 8
    Secondary Outcome Measure Information:
    Title
    Clinic blood pressure
    Time Frame
    Day 1 and day 8
    Title
    Plasma nitrate
    Time Frame
    Day 1 and day 8
    Title
    Dyspnoea using self report, validated Borg scale
    Time Frame
    Day 1 and day 8
    Title
    Oxygen saturation using pulse oximetry
    Time Frame
    Day 1 and day 8
    Title
    Plasma nitrite
    Time Frame
    Day 1 and day 8

    10. Eligibility

    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinically stable, Confirmed non-ischemic, dilated cardiomyopathy Exclusion Criteria: Active musculo-skeletal conditions Ischemic heart disease Pulmonary hypertension COPD Taking vasodilators Diabetes mellitus
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jim O 'Neill, MD
    Organizational Affiliation
    Connolly Hospital Blanchardstown
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Acute Dietary Nitrate in Dilated Cardiomyopathy

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