Food As Medicine for Heart Failure (FAM-HF)
Heart Failure, Malnutrition
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring heart failure, malnutrition, weight loss, cachexia, nutrition
Eligibility Criteria
Inclusion Criteria:
- Systolic heart failure (left ventricular ejection fraction </=40%), with New York Heart Association (NYHA) class II-III symptoms
- At least one prior hospitalization in the preceding 12 months
- Evidence of malnutrition on the Short Nutritional Assessment Questionnaire (SNAQ) screening tool for malnutrition (score of 2 or more)
- Have a fixed address within the Metro Boston region and availability of home refrigeration to accommodate the MTM deliveries
- Able and willing to sign study consent
- 18 years or above
- Not currently pregnant and not imminently planning a pregnancy
Exclusion Criteria:
- Prior heart transplantation or implantation of a left ventricular assist device
- Patients with a non-cardiac etiology for a skeletal muscle disorder e.g. muscular dystrophy, cancer
- Currently pregnant or planning to become pregnant
- Food allergy, aversion, or dietary preference that cannot be accommodated by Community Servings
- Systolic blood pressure at screening <90 mmHg, or heart rate >110 bpm
- Galactosemia
Sites / Locations
- Tufts Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
12 weeks of medically-tailored meals (MTMs)
12 weeks of protein supplementation shakes
12 weeks of home-delivered medically-tailored meals (MTMs), prepared and delivered by the non-profit Community Servings. The MTM has be developed specifically for patients with heart failure, with an approximate protein intake range of 1.1-1.5 g/kg body weight/day and a maximum of 2000 mg sodium/day.
Participants will receive 1 bottle of Ensure Max Protein shake every day (any flavor option without caffeine, daily for 12 weeks) to take in addition to their standard diet, without MTM delivery.