Heart Failure Clinical Trial

Acute Effects of Beet Juice Consumption on Exercise Capacity in Heart Failure

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.

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Full Description

Participants will complete up to four study visits. The first visit will involve completion of the informed consent process followed by a screening for study eligibility. The screening will consist of questionnaires pertaining to detailed medical history, diet, physical activity, and health-related quality of life (KCCQ). Anthropometric measures and a general health screening (including heart rate, resting blood pressure, and small blood (<15 mL) and urine samples will be collected). Volunteers meeting eligibility requirements will be scheduled for a screening maximal cardiopulmonary exercise test. Immediately prior to the exercise treadmill test, each subject will have a resting ECG and blood pressure to determine whether there are any abnormalities that would contraindicate exercise testing. Qualified subjects will then undergo a maximal cardiopulmonary exercise (CPX) test.

Following successful completion of the screening CPX test, volunteers meeting eligibility requirements will be scheduled for two testing visits, at least one week apart. At one visit, participants will consume a small cup of beet juice concentrate, and at the other, they will consume placebo. Treatment will be double-blinded and administered in random order.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Heart Failure

Phase:

Phase 1

Estimated Enrollment:

2

Study ID:

NCT01946542

Recruitment Status:

Terminated

Sponsor:

Jason Allen, Ph.D.

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There is 1 Location for this study

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Duke University Medical Center
Durham North Carolina, 27710, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 1

Estimated Enrollment:

2

Study ID:

NCT01946542

Recruitment Status:

Terminated

Sponsor:


Jason Allen, Ph.D.

How clear is this clinincal trial information?

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