Acute Dietary Nitrate in Dilated Cardiomyopathy
Primary Purpose
Cardiomyopathy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dietary nitrate
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Cardiomyopathy
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
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
NCT ID
NCT02471417
First Posted
January 7, 2015
Last Updated
June 10, 2015
Sponsor
Royal College of Surgeons, Ireland
Collaborators
University College Dublin, Connolly Hospital Blanchardstown
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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