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Acute Dietary Nitrate in Dilated Cardiomyopathy

R

Royal College of Surgeons, Ireland

Status

Completed

Conditions

Cardiomyopathy

Treatments

Dietary Supplement: Dietary nitrate
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02471417
Acute NO3- in DCM

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

12 participants in 2 patient groups, including a placebo group

Nitrate rich beetroot juice
Experimental group
Description:
Concentrated, beetroot juice is a rich source of dietary nitrate.
Treatment:
Dietary Supplement: Dietary nitrate
Nitrate depleted placebo beetroot juice
Placebo Comparator group
Description:
Placebo beetroot juice is identical to active beetroot juice in every way except nitrate content.
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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