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Trial record 13 of 538 for:    NITRATE ION

Acute Dietary Nitrate in Dilated Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02471417
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : June 15, 2015
Sponsor:
Collaborators:
University College Dublin
Connolly Hospital Blanchardstown
Information provided by (Responsible Party):
Royal College of Surgeons, Ireland

Tracking Information
First Submitted Date  ICMJE January 7, 2015
First Posted Date  ICMJE June 15, 2015
Last Update Posted Date June 15, 2015
Study Start Date  ICMJE January 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2015)
Change between incremental shuttle walk test distance pre and post juice [ Time Frame: Day 1 and day 8 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2015)
  • Clinic blood pressure [ Time Frame: Day 1 and day 8 ]
  • Plasma nitrate [ Time Frame: Day 1 and day 8 ]
  • Dyspnoea using self report, validated Borg scale [ Time Frame: Day 1 and day 8 ]
  • Oxygen saturation using pulse oximetry [ Time Frame: Day 1 and day 8 ]
  • Plasma nitrite [ Time Frame: Day 1 and day 8 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Dietary Nitrate in Dilated Cardiomyopathy
Official Title  ICMJE Dietary Nitrate Supplementation in Dilated Cardiomyopathy: An Acute, Double-blind, Randomized, Placebo-controlled, Crossover Trial.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Cardiomyopathy
Intervention  ICMJE
  • 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 Name: Beetroot juice
  • 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 Name: Nitrate depleted beetroot juice
Study Arms  ICMJE
  • Experimental: Nitrate rich beetroot juice
    Concentrated, beetroot juice is a rich source of dietary nitrate.
    Intervention: Dietary Supplement: Dietary nitrate
  • Placebo Comparator: Nitrate depleted placebo beetroot juice
    Placebo beetroot juice is identical to active beetroot juice in every way except nitrate content.
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2015)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE Not Provided
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02471417
Other Study ID Numbers  ICMJE Acute NO3- in DCM
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Royal College of Surgeons, Ireland
Study Sponsor  ICMJE Royal College of Surgeons, Ireland
Collaborators  ICMJE
  • University College Dublin
  • Connolly Hospital Blanchardstown
Investigators  ICMJE
Principal Investigator: Jim O 'Neill, MD Connolly Hospital Blanchardstown
PRS Account Royal College of Surgeons, Ireland
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP