N/A
Completed N=63
Nutritional Therapy Interventions in Heart Failure
Heart Failure NYHA Class II
Source: ClinicalTrials.gov NCT03424265 ↗
Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Functional Test — 115.91; 57.25 feet
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Test |
115.91; 57.25 | — |
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.
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. Informational only — not medical advice.