Acute Dietary Nitrate in Dilated Cardiomyopathy

June 10, 2015 updated by: Royal College of Surgeons, Ireland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change between incremental shuttle walk test distance pre and post juice
Time Frame: Day 1 and day 8
Day 1 and day 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinic blood pressure
Time Frame: Day 1 and day 8
Day 1 and day 8
Plasma nitrate
Time Frame: Day 1 and day 8
Day 1 and day 8
Dyspnoea using self report, validated Borg scale
Time Frame: Day 1 and day 8
Day 1 and day 8
Oxygen saturation using pulse oximetry
Time Frame: Day 1 and day 8
Day 1 and day 8
Plasma nitrite
Time Frame: Day 1 and day 8
Day 1 and day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal College of Surgeons, Ireland

Collaborators

University College Dublin
Connolly Hospital Blanchardstown

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

January 7, 2015

First Submitted That Met QC Criteria

June 10, 2015

First Posted (Estimate)

June 15, 2015

Study Record Updates

Last Update Posted (Estimate)

June 15, 2015

Last Update Submitted That Met QC Criteria

June 10, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Acute NO3- in DCM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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