NCT01946542

Brief Summary

The purpose of this project will be to determine whether consumption of beet juice concentrate prior to exercise may acutely improve exercise tolerance in patients with heart failure.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1 heart-failure

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_1 heart-failure

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 14, 2015

Completed
Last Updated

December 14, 2015

Status Verified

November 1, 2015

Enrollment Period

7 months

First QC Date

September 17, 2013

Results QC Date

September 28, 2015

Last Update Submit

November 10, 2015

Conditions

Heart Failure

Keywords

exerciseheart failurefatiguephysical endurancefunctional food

Outcome Measures

Primary Outcomes (1)

  • Exercise Tolerance

    treadmill time to exhaustion, cardiopulmonary exercise test

    Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)

Secondary Outcomes (1)

  • Vascular Function

    Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)

Study Arms (2)

placebo

PLACEBO COMPARATOR

placebo drink, single dose, taste and color-matched to experimental drink

Other: placebo

beet juice concentrate

EXPERIMENTAL

single dose of beet juice concentrate, roughly 70 mL

Drug: beet juice concentrate

Interventions

beet juice concentrateDRUG

single dose of beet juice concentrate, roughly 70 mL

beet juice concentrate
placeboOTHER
Also known as: placebo drink, single dose, taste and color-matched to experimental drink
placebo

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • New York Heart Association (NYHA) class II-III heart failure
  • receiving optimal medical therapy
  • sedentary

You may not qualify if:

  • smoking
  • changes in medication or major cardiovascular (CV) event or procedure within the previous 6 wk
  • fixed rate pacemaker
  • unstable angina
  • other co-morbidities or limitations that preclude safe participation in the exercise testing
  • plans for hospitalization or cardiac transplantation within the next 2 months
  • type 1 diabetes
  • refusal or inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • Kenjale AA, Ham KL, Stabler T, Robbins JL, Johnson JL, Vanbruggen M, Privette G, Yim E, Kraus WE, Allen JD. Dietary nitrate supplementation enhances exercise performance in peripheral arterial disease. J Appl Physiol (1985). 2011 Jun;110(6):1582-91. doi: 10.1152/japplphysiol.00071.2011. Epub 2011 Mar 31.

    PMID: 21454745BACKGROUND

MeSH Terms

Conditions

Heart FailureMotor ActivityFatigue

Interventions

Taste

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

The study was terminated due to low enrollment.

Results Point of Contact

Title
William Kraus
Organization
Duke University Medical Center
william.kraus@duke.edu
919-684-2063

Study Officials

  • William Kraus, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

September 17, 2013

First Posted

September 19, 2013

Study Start

February 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

December 14, 2015

Results First Posted

December 14, 2015

Record last verified: 2015-11

Locations

US(1)