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

Not Applicable

Completed

• Conditions: Systolic Heart Failure

• Registration Number: NCT02223403
• Lead Sponsor: Brooke Army Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-08
• Study First Submitted: 2014-08-20
• Study First Submitted QC: 2014-08-21
• Last Update Submitted: 2014-08-21
• Study First Posted: 2014-08-22
• Last Update Posted: 2014-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
six minute walk distance	six minutes	subjects walked at their chosen pace for six minutes on a pre-determined course. Total distance was recorded.
steady state exercise oxygen consumption	10 minutes	Subjects performed steady state treadmill walking at a pre-determine submaximal workload. Oxygen consumption was measured for the last 10 minutes.