N/A N=63 Randomized Triple-blind Basic Science

Nutritional Therapy Interventions in Heart Failure

Heart Failure NYHA Class II

Bottom Line

View on ClinicalTrials.gov: NCT03424265 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2020

Primary outcome: Primary: Functional Test — 115.91; 57.25 feet

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: EAA mixture (Dietary_supplement); Placebo (whey protein) (Dietary_supplement)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: University of Arkansas
Primary completion: Jun 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Functional Test	115.91; 57.25	—

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.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03424265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.