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Trial record 76 of 157 for:    Idiopathic Dilated Cardiomyopathy

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
Sponsor:
Collaborators:
University College Dublin
Connolly Hospital Blanchardstown
Information provided by (Responsible Party):
Royal College of Surgeons, Ireland

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.

Condition or disease Intervention/treatment Phase
Cardiomyopathy Dietary Supplement: Dietary nitrate Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change between incremental shuttle walk test distance pre and post juice [ Time Frame: Day 1 and day 8 ]

Secondary Outcome Measures :
  1. Clinic blood pressure [ Time Frame: Day 1 and day 8 ]
  2. Plasma nitrate [ Time Frame: Day 1 and day 8 ]
  3. Dyspnoea using self report, validated Borg scale [ Time Frame: Day 1 and day 8 ]
  4. Oxygen saturation using pulse oximetry [ Time Frame: Day 1 and day 8 ]
  5. Plasma nitrite [ Time Frame: Day 1 and day 8 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Royal College of Surgeons, Ireland
University College Dublin
Connolly Hospital Blanchardstown
Investigators
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Principal Investigator: Jim O 'Neill, MD Connolly Hospital Blanchardstown

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Responsible Party: Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier: NCT02471417     History of Changes
Other Study ID Numbers: Acute NO3- in DCM
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: June 15, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly