DASH Diet in Heart Failure Outpatients

NCT05117086 | Active Not Recruiting

• 1 other identifier: 1770356
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (9)

• Dietary intake

  Dietary intake assessed by nutrient analysis of food records

  Dietary intake at baseline

• Dietary intake

  Dietary intake assessed by nutrient analysis of food records

  Dietary intake at 3 months

• Dietary intake

  Dietary intake assessed by nutrient analysis of food records

  Dietary intake at 6 months

• Diet score

  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.

  Dietary intake at baseline

• Diet score

  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.

  Dietary intake at 3 months

• Diet score

  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.

  Dietary intake at 6 months

• Blood Pressure

  Blood Pressure assessed with systolic and diastolic pressure

  Systolic and diastolic Blood Pressure at baseline

• Blood Pressure

  Blood Pressure assessed with systolic and diastolic pressure

  Systolic and diastolic Blood Pressure at 3 months

• Blood Pressure

  Blood Pressure assessed with systolic and diastolic pressure

  Systolic and diastolic Blood Pressure at 6 months

Secondary Outcomes (9)

• Heart Failure clinical marker

  proBNP at baseline

• Heart Failure clinical marker

  proBNP at 3 months

• Heart Failure clinical marker

  proBNP at 6 months

• Patient report of HF symptoms

  KCCQ at baseline

• Patient report of HF symptoms

  KCCQ at 3 months

Study Arms (1)

Dietary Intervention Arm

EXPERIMENTAL

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.

Behavioral: DASH diet

Interventions

DASH diet BEHAVIORAL

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

Dietary Intervention Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• American College of Cardiology: collaborator

Study Sites (1)

UC Davis Health Center - Cardiology Department

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Dietary Approaches To Stop Hypertension

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Francene Steinberg, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm pragmatic trial with pre- and post- assessments

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 11, 2021
• Study Start: February 1, 2022
• Primary Completion (Estimated): June 11, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)