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DASH Diet in Heart Failure Outpatients (DASH-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05117086
Recruitment Status : Recruiting
First Posted : November 11, 2021
Last Update Posted : February 11, 2022
Sponsor:
Collaborator:
American College of Cardiology
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: DASH diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm pragmatic trial with pre- and post- assessments
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official 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
Actual Study Start Date : February 1, 2022
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: 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.
Behavioral: DASH diet
Nutrition education and counseling on DASH diet, behavioral and lifestyle modifications




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05117086


Contacts
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Contact: Francene Steinberg, PhD 530 752 0160 fmsteinberg@ucdavis.edu
Contact: Brooke Wickman, MS bewickman@ucdavis.edu

Locations
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United States, California
UC Davis Health Center - Cardiology Department Recruiting
Sacramento, California, United States, 95817
Contact: Francene M Steinberg, PhD, RD    530-752-0160    fmsteinberg@ucdavis.edu   
Contact: Camryn Sellers-Porter, BS       cmsellers@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
American College of Cardiology
Investigators
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Principal Investigator: Francene Steinberg, PhD University of California, Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT05117086    
Other Study ID Numbers: 1770356
First Posted: November 11, 2021    Key Record Dates
Last Update Posted: February 11, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases