Status:
COMPLETED
Food As Medicine for Heart Failure
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
Community Servings
Conditions:
Heart Failure
Malnutrition
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Malnutrition and unintentional weight loss are highly prevalent among patients with heart failure (HF), with approximately 50% of patients with heart failure meeting malnutrition criteria. Poor dietar...
Detailed Description
We plan to conduct a single-center pilot trial to assess the tolerability, feasibility, and efficacy of providing medically-tailored meals to patients with heart failure with reduced ejection fraction...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04847973
Start Date
April 16 2021
End Date
December 31 2023
Last Update
March 19 2024
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111