Effect of Nitrate-rich Beetroot Juice on Exercise Performance in Heart Failure Patients

Systolic Heart Failure Clinical Trial

Official title:

Single Dose of Nitrate-rich Beetroot Juice Does Not Improve Steady State Oxygen Consumption or Six-minute Walk Distance in Patients With Systolic Heart Failure.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02223403
• Other study ID #: 383967-4
• Status: Completed
• Phase: N/A
• First received: August 20, 2014
• Last updated: August 21, 2014
• Start date: October 2012
• Est. completion date: May 2014

Study information

• Verified date: August 2014
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Nitrate-rich beetroot juice supplementation has demonstrated reduced oxygen consumption and submaximal exercise performance in healthy adults. Investigation for similar effects in patients with heart failure has not previously been conducted.

This was a randomized, double-blind, placebo controlled trial. Following ingestion of the active agent or placebo, subjects with systolic heart failure underwent submaximal steady state exercise with gas exchange analysis followed thirty minutes later by a six minute walk test. Second testing sessions were performed ten days.

There were no significant differences in the treatment and placebo arms in average oxygen consumption or six minute walk distance.

In conclusion, in patients with heart failure who have ingested a single dose of nitrate-rich beetroot juice concentrate, there is no significant difference with regard to oxygen consumption during submaximal steady state exercise or six minute walk testing distance.

Further study is warranted to determine the true efficacy of nitrate consumption in this population with adjustments in acute or chronic dosing, exercise duration, or intensity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Local institutional beneficiaries between the ages of 18 and 80

• Documentation of left ventricular systolic dysfunction with ejection fraction < 40% by any modality within the past six months

• Documentation of New York Heart Association class II or III status.

Exclusion Criteria:

• > 80 years of age

• Unable to adequately or safely perform treadmill exercise

• Pulmonary disease deemed significant enough to be a limitation to exercise

• Greater than moderate stenotic or regurgitant valvular heart disease

• Presence of atrial fibrillation or other uncontrolled arrhythmias

• Uncompensated heart failure

• Continuously paced rhythms

• Pregnant females

• Chronic nitroglycerine use (oral isosorbide di or mono-nitrate, or topical nitroglycerine)

• Phosphodiesterase inhibitor (sildenafil or tadalafil) use within a week

Study Design

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic
• Systolic Heart Failure

Intervention

Dietary Supplement:
• nitrate-rich beetroot juice
3 ounces of nitrate-rich beetroot juice ingested orally once 90 minutes before exercise interventions of steady state treadmill exercise followed 30 minutes later by six minute walk
• nitrate-deplete beetroot juice
3 ounces of nitrate-deplete beetroot juice ingested orally once 90 minutes before exercise interventions of steady state treadmill exercise followed 30 minutes later by six minute walk

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	steady state exercise oxygen consumption	Subjects performed steady state treadmill walking at a pre-determine submaximal workload. Oxygen consumption was measured for the last 10 minutes.	10 minutes	No
Primary	six minute walk distance	subjects walked at their chosen pace for six minutes on a pre-determined course. Total distance was recorded.	six minutes	No