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Completed

NCT Number: NCT02471417

Acute Dietary Nitrate in Dilated Cardiomyopathy

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.

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Key information

Conditions

Cardiomyopathy Cardiomyopathies Cardiovascular Diseases Heart Diseases

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Dietary nitrate

Dietary Supplement

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

Dietary Supplement

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

Primary outcomes

  1. Change between incremental shuttle walk test distance pre and post juice

    Time frame: Day 1 and day 8

Secondary outcomes

  1. Clinic blood pressure

    Time frame: Day 1 and day 8

  2. Plasma nitrate

    Time frame: Day 1 and day 8

  3. Dyspnoea using self report, validated Borg scale

    Time frame: Day 1 and day 8

  4. Oxygen saturation using pulse oximetry

    Time frame: Day 1 and day 8

  5. Plasma nitrite

    Time frame: Day 1 and day 8

Sponsors and collaborators

Lead sponsor

Royal College of Surgeons, Ireland

Other

Collaborators

  • Connolly Hospital Blanchardstown
  • University College Dublin

Registry information

Official study title

Dietary Nitrate Supplementation in Dilated Cardiomyopathy: An Acute, Double-blind, Randomized, Placebo-controlled, Crossover Trial.

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 15, 2015
Registry last updated
Jun 15, 2015

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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