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Acute Dietary Nitrate in Dilated Cardiomyopathy

Sponsor
Royal College of Surgeons, Ireland (Other)
Overall Status
Completed
CT.gov ID
NCT02471417
Collaborator
University College Dublin (Other), Connolly Hospital Blanchardstown (Other)
12
Enrollment
2
Arms
3.9
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Dietary nitrate
  • Dietary Supplement: Placebo
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Dietary Nitrate Supplementation in Dilated Cardiomyopathy: An Acute, Double-blind, Randomized, Placebo-controlled, Crossover Trial.
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nitrate rich beetroot juice

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

Dietary Supplement: Dietary nitrate
140ml of nitrate rich beetroot juice provides 12.9mmol nitrate and will be on a single occasion by the study subjects.
Other Names:
  • Beetroot juice

    		•
    Placebo Comparator: Nitrate depleted placebo beetroot juice

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

    Dietary Supplement: Placebo
    140ml of nitrate depleted beetroot juice provides 0.5mmol nitrate and will be on a single occasion by the study subjects.
    Other Names:
  • Nitrate depleted beetroot juice

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change between incremental shuttle walk test distance pre and post juice [Day 1 and day 8]

    Secondary Outcome Measures

    1. Clinic blood pressure [Day 1 and day 8]

    2. Plasma nitrate [Day 1 and day 8]

    3. Dyspnoea using self report, validated Borg scale [Day 1 and day 8]

    4. Oxygen saturation using pulse oximetry [Day 1 and day 8]

    5. Plasma nitrite [Day 1 and day 8]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Royal College of Surgeons, Ireland
    • University College Dublin
    • Connolly Hospital Blanchardstown

    Investigators

    • Principal Investigator: Jim O 'Neill, MD, Connolly Hospital Blanchardstown

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Royal College of Surgeons, Ireland
    ClinicalTrials.gov Identifier:
    NCT02471417
    Other Study ID Numbers:
    • Acute NO3- in DCM
    First Posted:
    Jun 15, 2015
    Last Update Posted:
    Jun 15, 2015
    Last Verified:
    Jun 1, 2015
    Additional relevant MeSH terms:
    Cardiomyopathies
    Cardiomyopathy, Dilated

    Study Results

    No Results Posted as of Jun 15, 2015