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NCT Number: NCT05117086

DASH Diet in Heart Failure Outpatients

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Health Center - Cardiology Department

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DASH diet

Behavioral

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

Primary outcomes

  1. Dietary intake

    Time frame: Dietary intake at baseline

    Dietary intake assessed by nutrient analysis of food records

  2. Dietary intake

    Time frame: Dietary intake at 3 months

    Dietary intake assessed by nutrient analysis of food records

  3. Dietary intake

    Time frame: Dietary intake at 6 months

    Dietary intake assessed by nutrient analysis of food records

  4. Diet score

    Time frame: Dietary intake at baseline

    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.

  5. Diet score

    Time frame: Dietary intake at 3 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.

  6. Diet score

    Time frame: 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.

  7. Blood Pressure

    Time frame: Systolic and diastolic Blood Pressure at baseline

    Blood Pressure assessed with systolic and diastolic pressure

  8. Blood Pressure

    Time frame: Systolic and diastolic Blood Pressure at 3 months

    Blood Pressure assessed with systolic and diastolic pressure

  9. Blood Pressure

    Time frame: Systolic and diastolic Blood Pressure at 6 months

    Blood Pressure assessed with systolic and diastolic pressure

Secondary outcomes

  1. Heart Failure clinical marker

    Time frame: proBNP at baseline

    proBNP will be assessed as a marker of severity of heart failure

  2. Heart Failure clinical marker

    Time frame: proBNP at 3 months

    proBNP will be assessed as a marker of severity of heart failure

  3. Heart Failure clinical marker

    Time frame: proBNP at 6 months

    proBNP will be assessed as a marker of severity of heart failure

  4. Patient report of HF symptoms

    Time frame: KCCQ at baseline

    Kansas City Cardiomyopathy Questionnaire (KCCQ) will assess patient report of symptoms. Minimum to Maximum values: 0-100. Higher scores represent better outcome.

  5. Patient report of HF symptoms

    Time frame: KCCQ at 3 months

    Kansas City Cardiomyopathy Questionnaire (KCCQ) will assess patient report of symptoms. Minimum to Maximum values: 0-100. Higher scores represent better outcome.

  6. Patient report of HF symptoms

    Time frame: 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.

  7. Patient report of eating habit self efficacy

    Time frame: Eating Habits at Baseline

    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.

  8. Patient report of eating habit self efficacy

    Time frame: Eating Habits at 3 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.

  9. Patient report of eating habit self efficacy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • American College of Cardiology

Registry information

Official study title

DASH Diet in Heart Failure Pilot Study - Integration and Effectiveness of Medical Nutrition Therapy Counseling on DASH Diet in the Management of Heart Failure Patients in an Academic Outpatient Cardiology Clinic

Acronym: DASH-HF

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 11, 2021
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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