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Acute Dietary Nitrate in Dilated Cardiomyopathy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02471417
Enrollment
12
Registered
2015-06-15
Start date
2015-01-31
Completion date
2015-05-31
Last updated
2015-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathy

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.

Interventions

DIETARY_SUPPLEMENTDietary nitrate

140ml of nitrate rich beetroot juice provides 12.9mmol nitrate and will be on a single occasion by the study subjects.

DIETARY_SUPPLEMENTPlacebo

140ml of nitrate depleted beetroot juice provides 0.5mmol nitrate and will be on a single occasion by the study subjects.

Sponsors

University College Dublin
CollaboratorOTHER
Connolly Hospital Blanchardstown
CollaboratorOTHER
Royal College of Surgeons, Ireland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change between incremental shuttle walk test distance pre and post juiceDay 1 and day 8

Secondary

MeasureTime frame
Clinic blood pressureDay 1 and day 8
Plasma nitrateDay 1 and day 8
Dyspnoea using self report, validated Borg scaleDay 1 and day 8
Oxygen saturation using pulse oximetryDay 1 and day 8
Plasma nitriteDay 1 and day 8

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026