DASH Diet in Heart Failure Outpatients

Not Applicable

Active, not recruiting

• Conditions: Heart Failure
• Interventions: Behavioral: DASH diet

• Registration Number: NCT05117086
• Lead Sponsor: University of California, Davis

Brief Summary

The purpose of this study is to refine the classification of the effectiveness of the DASH diet for outpatient heart failure (HF) management, using behavioral, clinical, and laboratory correlative science approaches.

Detailed Description

The overall objective of this pilot study is to refine the classification of the effectiveness of the DASH diet for outpatient HF management using behavioral, clinical, and laboratory correlative science approaches. The investigators will integrate the use and evaluation of DASH diet nutrition education in a clinical population using a pragmatic study approach. The investigators will assess dietary behavior change. The investigators will assess the medical effectiveness of the DASH diet to improve patient symptomology and clinical biomarkers. Exploratory investigations will involve metabolomics analyses of plasma samples for biomarker discovery of clinical phenotypes in HF patients, to characterize metabolic profiles related to dietary exposure.

Study Timeline

• Study First Submitted: 2021-11-01
• Study First Submitted QC: 2021-11-01
• Study First Posted: 2021-11-11
• Study Start: 2022-02-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-06-11
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Heart Failure diagnosis
• Guideline directed medical therapy optimization on stable regimen at least 30 days

Exclusion Criteria

• BMI < 18/5 kg/m squared
• cardiac cachexia
• end-stage renal disease or dialysis
• acute inflammatory condition
• uncontrolled arrhythmias or ischemia
• status post heart transplant or implanted left ventricular assist device

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dietary Intervention Arm	DASH diet	Subjects will receive the active intervention of nutrition education and medical nutrition therapy counseling for dietary and behavioral lifestyle changes. The focus will be on DASH diet implementation and adherence for management of heart failure. The subjects will have 4 study visits with a Registered Dietitian over 6 months (visits at 1, 2, 3, and 6 months). Outcome measures will be assessed at baseline, 3 and 6 months.

Primary Outcome Measures

Name	Time	Method
Dietary intake	Dietary intake at 6 months	Dietary intake assessed by nutrient analysis of food records
Blood Pressure	Systolic and diastolic Blood Pressure at 6 months	Blood Pressure assessed with systolic and diastolic pressure
Diet score	Dietary intake at 6 months	Dietary intake assessed by calculation of DASH diet score (Dietary Approaches to Stop Hypertension diet score). Minimum to Maximum values: 8-40 Higher scores mean better outcome and diet composition.

Secondary Outcome Measures

Name	Time	Method
Patient report of HF symptoms	KCCQ at 6 months	Kansas City Cardiomyopathy Questionnaire (KCCQ) will assess patient report of symptoms. Minimum to Maximum values: 0-100. Higher scores represent better outcome.
Heart Failure clinical marker	proBNP at 6 months	proBNP will be assessed as a marker of severity of heart failure
Patient report of eating habit self efficacy	Eating Habits at 6 months	Eating Habits Questionnaire will assess patient report of self efficacy for behavior change around DASH diet eating habits. Minimum to Maximum values:27-135. Higher value is better outcome.

Trial Locations

Locations (1)

UC Davis Health Center - Cardiology Department; 🇺🇸 Sacramento, California, United States