Acute Dietary Nitrate in Dilated Cardiomyopathy
Dietary Nitrate Supplementation in Dilated Cardiomyopathy: An Acute, Double-blind, Randomized, Placebo-controlled, Crossover Trial.
1 other identifier
interventional
12
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 15, 2015
CompletedJune 15, 2015
June 1, 2015
4 months
January 7, 2015
June 10, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change between incremental shuttle walk test distance pre and post juice
Day 1 and day 8
Secondary Outcomes (5)
Clinic blood pressure
Day 1 and day 8
Plasma nitrate
Day 1 and day 8
Dyspnoea using self report, validated Borg scale
Day 1 and day 8
Oxygen saturation using pulse oximetry
Day 1 and day 8
Plasma nitrite
Day 1 and day 8
Study Arms (2)
Nitrate rich beetroot juice
EXPERIMENTALConcentrated, beetroot juice is a rich source of dietary nitrate.
Nitrate depleted placebo beetroot juice
PLACEBO COMPARATORPlacebo beetroot juice is identical to active beetroot juice in every way except nitrate content.
Interventions
140ml of nitrate rich beetroot juice provides 12.9mmol nitrate and will be on a single occasion by the study subjects.
140ml of nitrate depleted beetroot juice provides 0.5mmol nitrate and will be on a single occasion by the study subjects.
Eligibility Criteria
You may qualify if:
- Clinically stable,
- Confirmed non-ischemic, dilated cardiomyopathy
You may not qualify if:
- Active musculo-skeletal conditions
- Ischemic heart disease
- Pulmonary hypertension
- COPD
- Taking vasodilators
- Diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royal College of Surgeons, Irelandlead
- University College Dublincollaborator
- Connolly Hospital Blanchardstowncollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jim O 'Neill, MD
Connolly Hospital Blanchardstown
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2015
First Posted
June 15, 2015
Study Start
January 1, 2015
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
June 15, 2015
Record last verified: 2015-06