Status:
COMPLETED
Nutritional Therapy Interventions in Heart Failure
Lead Sponsor:
University of Arkansas
Conditions:
Heart Failure NYHA Class II
Eligibility:
All Genders
60-89 years
Phase:
NA
Brief Summary
The investigators will examine the effects of 12-weeks of nutritional interventions in older participants who have a symptom of mild to moderate heart failure.
Detailed Description
Heart failure develops when cardiac muscle becomes weakened and consequently is compromised in its ability to contract, relax, or both. Impaired heart function leads to reduced exercise capacity, whic...
Eligibility Criteria
Inclusion
- BMI between 18 and 40 kg/m2
- Any ethnicity
- Presence of mild-to-moderate heart failure (NYHA II or III symptomatology) as evidenced by prescribed diuretics or reported shortness of breath upon exertion
Exclusion
- Allergic to milk or soy products
- Hemoglobin \<10 g/dL
- Estimated Glomerular Filtration Rate (eGFR) \< 30
- Inability to perform strength and/or functional assessments
- Myocardial infarction in the past 6 months
- Unstable angina
- Moderate-severe heart valve disease
- Atrial fibrillation or other significant (as determined by PI) arrhythmias
- Infiltrative, restrictive or hypertrophic cardiomyopathy
- Dementia -determined by a SLUMS score of \<20
- Currently having inflammatory bowel disease
- Received chemotherapy or radiation therapy within the past 12 months
- Currently undergoing tube feeding
- Currently receiving palliative care for end-of-life circumstance
- Unwilling to refrain from using non-study protein/amino acid supplements during their participation in this study
- If deemed medically unstable by the study physician for any other reason.
Key Trial Info
Start Date :
February 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2019
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT03424265
Start Date
February 15 2018
End Date
June 27 2019
Last Update
July 12 2021
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205