Acute Dietary Nitrate in Dilated Cardiomyopathy

Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02471417
• Other study ID #: Acute NO3- in DCM
• Status: Completed
• Phase: N/A
• First received: January 7, 2015
• Last updated: June 10, 2015
• Start date: January 2015
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Royal College of Surgeons, Ireland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Cardiomyopathy, Dilated

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Royal College of Surgeons, Ireland	Connolly Hospital Blanchardstown, University College Dublin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change between incremental shuttle walk test distance pre and post juice		Day 1 and day 8	No
Secondary	Clinic blood pressure		Day 1 and day 8	Yes
Secondary	Plasma nitrate		Day 1 and day 8	Yes
Secondary	Dyspnoea using self report, validated Borg scale		Day 1 and day 8	Yes
Secondary	Oxygen saturation using pulse oximetry		Day 1 and day 8	Yes
Secondary	Plasma nitrite		Day 1 and day 8	No