Heart Failure Food Intervention Trial: Impact of a Guideline-based Nutrition Digital Tool in Heart Failure Patient Clinical Outcomes

Not Applicable

• Conditions: Heart Failure

• Registration Number: NCT06999369
• Lead Sponsor: Sutter Health

Brief Summary

Measuring the impact of a guideline-based nutrition digital tool in heart failure patients

Detailed Description

The goal of this research clinical trial is to learn understand or learn whether a guideline-based nutrition application (app) called MedChefs can help heart failure patients adopt and sustain an evidence-based dietary patterns.

Study Timeline

• Study Start: 2025-02-25
• Status Verified: 2025-05
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Study First Posted: 2025-05-31
• Last Update Posted: 2025-05-31
• Primary Completion: 2026-08-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• 18-89 years old at time of enrollment
• Any type of Heart failure diagnosis (e.g., I50.x) between 1/1/2023-present
• Recent hospital admission (within a year)
• Race/ethnicity: All race/ethnic groups
• Location: patients have been treated in the Greater East Bay division and Greater Silicon Valley division areas.
• Patients with have at least 1 office/outpatient visit with a primary care physician or cardiologist visit before index date

Exclusion Criteria

• • Patients with certain patient history (cognitive disabilities) and end stage renal or metastatic cancer diagnosis

  • Patients with active drug/substance use. Patients with heart failure who have active substance use are excluded from the study. HF patients with substance use require additional monitoring and follow up due to potential severe withdrawal symptoms, acute HF exacerbation and drug overdose or medication errors. Standard protocol includes additional monitor vital signs (e.g., blood pressure, heart rate) and HF symptoms (e.g., edema, dyspnea), and performing regular laboratory tests (e.g., renal function, electrolytes) which is beyond the clinical and logistical capabilities of this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Blood Pressure	Baseline and 6 months	Blood pleasure will be measure by mmHg

Secondary Outcome Measures

Name	Time	Method
Weight	Baseline and 6 months	Weight will be measured in pounds

Trial Locations

Locations (1)

2121 N. California Blvd., Suite 310; 🇺🇸 Walnut Creek, California, United States