Status:
COMPLETED
Comparative Effectiveness of 7 Versus 21 Home-delivered Medically Tailored Meals to Improve Malnutrition Risk in Malnourished Patients With Heart Failure
Lead Sponsor:
University of Pennsylvania
Conditions:
Heart Failure
Malnutrition
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
This protocol is designed to compare the effectiveness of two dietary intervention doses for patients with heart failure (HF) and malnutrition risk or malnutrition at hospital discharge. This random o...
Detailed Description
1.1 Background and Relevant Literature Heart failure (HF) is a common clinical syndrome occurring in 6.2 million adults in the US with a cost of $30.7 million in 2012 due to health care services, medi...
Eligibility Criteria
Inclusion
- Age ≥ 18
- Diagnosis of Heart Failure (NYHA Class 1-3/ ACC/AHA Stage C) and moderate or severe malnutrition or malnutrition risk
- Residence within MANNA delivery area
Exclusion
- \>90 years of age
- Dementia/cognitive decline
- Heart Failure stage 4 or D
- Chronic kidney disease stage 5 or dialysis-dependent (GFR\<30 mL/min/1.72 m2)
- Unstable COPD as COPD flare within prior 3 months
- Active cancer therapy
- Pregnancy
- Living in a residential facility such as prison, long-term care, rehabilitation, other
- Allergy to foods on the menus
- Persistent hyperkalemia (\> 5 mEq/L) more than twice without excess potassium intake during hospital admission
- Persistent hypotension (systolic BP\<100 mm Hg) during the hospital admission
- Systolic BP\> 180 or diastolic BP \>100 mmHg
- Active substance or alcohol abuse
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06142903
Start Date
August 1 2022
End Date
February 1 2024
Last Update
February 20 2025
Active Locations (1)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104