Systolic Heart FailureNCT02223403
Effect of Nitrate-rich Beetroot Juice on Exercise Performance in Heart Failure Patients
A study testing nitrate-rich beetroot juice and nitrate-deplete beetroot juice in people with Systolic Heart Failure, run by Brooke Army Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Systolic Heart Failure
- What is being tested?
- nitrate-rich beetroot juice and nitrate-deplete beetroot juice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- > 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
Show all 10Show fewer
- 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
About this study
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.
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.
Read more
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.
- Conditions
- Systolic Heart Failure
- Being tested
- nitrate-rich beetroot juice, nitrate-deplete beetroot juice
- Keywords
- Nitrate-rich beetroot juice, heart failure, exercise performance, oxygen consumption
- Medical subject headings
- Heart Failure, Systolic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nitrate-rich beetroot juiceDietary supplement
Also called Beet It Sport Stamina Shot
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 juiceDietary supplement
Also called Beet It Sport Stamina Shot
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
| Study group | Role | What they receive |
|---|---|---|
| submaximal steady state exercise | Experimental | 90 minutes after respective beetroot juice ingestion, subjects walked on treadmill at a pre-determined steady state workload for a total of 15 minutes with oxygen consumption recorded for the last 10 minutes Receives: Dietary Supplement: nitrate-rich beetroot juice; Dietary Supplement: nitrate-deplete beetroot juice |
| six minute walk test | Experimental | subjects performed six-minute walk at self-determined pace 30 minutes after treadmill exercise was performed Receives: Dietary Supplement: nitrate-rich beetroot juice; Dietary Supplement: nitrate-deplete beetroot juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
six minute walk distance
subjects walked at their chosen pace for six minutes on a pre-determined course. Total distance was recorded.
Measured: six minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startOct 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systolic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Kenneth M Leclerc, Brooke Army Medical Center
- Investigators
- Kenneth M Leclerc, MD, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223403
- Sponsor's protocol ID
- 383967-4
- Status last verified
- Aug 2014
- First submitted
- 20 Aug 2014
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02223403
- Acronym / sponsor ID
- 383967-4
- Conditions
- Systolic Heart Failure
- Keywords
- Nitrate-rich beetroot juice, heart failure, exercise performance, oxygen consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- Oct 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| submaximal steady state exercise | Experimental | Dietary Supplement: nitrate-rich beetroot juice, Dietary Supplement: nitrate-deplete beetroot juice90 minutes after respective beetroot juice ingestion, subjects walked on treadmill at a pre-determined steady state workload for a total of 15 minutes with oxygen consumption recorded for the last 10 minutes |
| six minute walk test | Experimental | Dietary Supplement: nitrate-rich beetroot juice, Dietary Supplement: nitrate-deplete beetroot juicesubjects performed six-minute walk at self-determined pace 30 minutes after treadmill exercise was performed |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- > 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nitrate-rich beetroot juiceAlso: Beet It Sport Stamina Shot3 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 | Dietary supplement | six minute walk test, submaximal steady state exercise |
| nitrate-deplete beetroot juiceAlso: Beet It Sport Stamina Shot3 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 | Dietary supplement | six minute walk test, submaximal steady state exercise |
Primary outcome
steady state exercise oxygen consumption
Time frame: 10 minutes
Subjects performed steady state treadmill walking at a pre-determine submaximal workload. Oxygen consumption was measured for the last 10 minutes.
six minute walk distance
Time frame: six minutes
subjects walked at their chosen pace for six minutes on a pre-determined course. Total distance was recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
Related trials for Systolic Heart Failure
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 3
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
RecruitingPhase 1/2
Endocardial Delivery for Myocardial Regeneration Using Allogeneic iPSC-derived Cardiomyocyte Spheroids for HF With Systolic Dysfunction (EMERALD Study)
Heart Failure, Ischemic Heart Failure
Recruiting
Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing
Heart Failure, Systolic Bundle Branch Block, Left
Recruiting
The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)
Coronary Artery Disease, Heart Failure Systolic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth M Leclerc, MD principal investigator
Brooke Army Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing nitrate-rich beetroot juice and nitrate-deplete beetroot juice in people with Systolic Heart Failure, run by Brooke Army Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
steady state exercise oxygen consumption (time frame: 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2014.