Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-24 @ 7:11 PM
NCT ID:
NCT06142903
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
1. \>90 years of age
2. Dementia/cognitive decline
3. Heart Failure stage 4 or D
4. Chronic kidney disease stage 5 or dialysis-dependent (GFR\<30 mL/min/1.72 m2)
5. Unstable COPD as COPD flare within prior 3 months
6. Active cancer therapy
7. Pregnancy
8. Living in a residential facility such as prison, long-term care, rehabilitation, other
9. Allergy to foods on the menus
10. Persistent hyperkalemia (\> 5 mEq/L) more than twice without excess potassium intake during hospital admission
11. Persistent hypotension (systolic BP\<100 mm Hg) during the hospital admission
12. Systolic BP\> 180 or diastolic BP \>100 mmHg
13. Active substance or alcohol abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT06142903
Study Brief:
Protocol Section:
NCT06142903