DASH Diet in Heart Failure Outpatients

NCT ID: NCT05117086

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2026-12-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Dietary Intervention Arm

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.

Group Type: EXPERIMENTAL

DASH diet

Intervention Type: BEHAVIORAL

Nutrition education and counseling on DASH diet, behavioral and lifestyle modifications

Interventions

DASH diet

Nutrition education and counseling on DASH diet, behavioral and lifestyle modifications

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American College of Cardiology

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francene Steinberg, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

UC Davis Health Center - Cardiology Department

Sacramento, California, United States

Countries

United States

Other Identifiers

1770356

Identifier Type: -

Identifier Source: org_study_id