Acute Dietary Nitrate in Dilated Cardiomyopathy
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|ClinicalTrials.gov Identifier: NCT02471417|
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : June 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cardiomyopathy||Dietary Supplement: Dietary nitrate Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Dietary Nitrate Supplementation in Dilated Cardiomyopathy: An Acute, Double-blind, Randomized, Placebo-controlled, Crossover Trial.|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
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 Name: 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 Name: Nitrate depleted beetroot juice
- Change between incremental shuttle walk test distance pre and post juice [ Time Frame: Day 1 and day 8 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471417
|Principal Investigator:||Jim O 'Neill, MD||Connolly Hospital Blanchardstown|