DASH Diet in Heart Failure Outpatients (DASH-HF)
Primary Purpose
Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DASH diet
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure
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
Sites / Locations
- UC Davis Health Center - Cardiology DepartmentRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dietary Intervention Arm
Arm Description
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.
Outcomes
Primary Outcome Measures
Dietary intake
Dietary intake assessed by nutrient analysis of food records
Dietary intake
Dietary intake assessed by nutrient analysis of food records
Dietary intake
Dietary intake assessed by nutrient analysis of food records
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.
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.
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.
Blood Pressure
Blood Pressure assessed with systolic and diastolic pressure
Blood Pressure
Blood Pressure assessed with systolic and diastolic pressure
Blood Pressure
Blood Pressure assessed with systolic and diastolic pressure
Secondary Outcome Measures
Heart Failure clinical marker
proBNP will be assessed as a marker of severity of heart failure
Heart Failure clinical marker
proBNP will be assessed as a marker of severity of heart failure
Heart Failure clinical marker
proBNP will be assessed as a marker of severity of heart failure
Patient report of HF symptoms
Kansas City Cardiomyopathy Questionnaire (KCCQ) will assess patient report of symptoms. Minimum to Maximum values: 0-100. Higher scores represent better outcome.
Patient report of HF symptoms
Kansas City Cardiomyopathy Questionnaire (KCCQ) will assess patient report of symptoms. Minimum to Maximum values: 0-100. Higher scores represent better outcome.
Patient report of HF symptoms
Kansas City Cardiomyopathy Questionnaire (KCCQ) will assess patient report of symptoms. Minimum to Maximum values: 0-100. Higher scores represent better outcome.
Patient report of eating habit self efficacy
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.
Patient report of eating habit self efficacy
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.
Patient report of eating habit self efficacy
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.
Full Information
NCT ID
NCT05117086
First Posted
November 1, 2021
Last Updated
February 9, 2022
Sponsor
University of California, Davis
Collaborators
American College of Cardiology
1. Study Identification
Unique Protocol Identification Number
NCT05117086
Brief Title
DASH Diet in Heart Failure Outpatients
Acronym
DASH-HF
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
American College of Cardiology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm pragmatic trial with pre- and post- assessments
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dietary Intervention Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DASH diet
Intervention Description
Nutrition education and counseling on DASH diet, behavioral and lifestyle modifications
Primary Outcome Measure Information:
Title
Dietary intake
Description
Dietary intake assessed by nutrient analysis of food records
Time Frame
Dietary intake at baseline
Title
Dietary intake
Description
Dietary intake assessed by nutrient analysis of food records
Time Frame
Dietary intake at 3 months
Title
Dietary intake
Description
Dietary intake assessed by nutrient analysis of food records
Time Frame
Dietary intake at 6 months
Title
Diet score
Description
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.
Time Frame
Dietary intake at baseline
Title
Diet score
Description
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.
Time Frame
Dietary intake at 3 months
Title
Diet score
Description
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.
Time Frame
Dietary intake at 6 months
Title
Blood Pressure
Description
Blood Pressure assessed with systolic and diastolic pressure
Time Frame
Systolic and diastolic Blood Pressure at baseline
Title
Blood Pressure
Description
Blood Pressure assessed with systolic and diastolic pressure
Time Frame
Systolic and diastolic Blood Pressure at 3 months
Title
Blood Pressure
Description
Blood Pressure assessed with systolic and diastolic pressure
Time Frame
Systolic and diastolic Blood Pressure at 6 months
Secondary Outcome Measure Information:
Title
Heart Failure clinical marker
Description
proBNP will be assessed as a marker of severity of heart failure
Time Frame
proBNP at baseline
Title
Heart Failure clinical marker
Description
proBNP will be assessed as a marker of severity of heart failure
Time Frame
proBNP at 3 months
Title
Heart Failure clinical marker
Description
proBNP will be assessed as a marker of severity of heart failure
Time Frame
proBNP at 6 months
Title
Patient report of HF symptoms
Description
Kansas City Cardiomyopathy Questionnaire (KCCQ) will assess patient report of symptoms. Minimum to Maximum values: 0-100. Higher scores represent better outcome.
Time Frame
KCCQ at baseline
Title
Patient report of HF symptoms
Description
Kansas City Cardiomyopathy Questionnaire (KCCQ) will assess patient report of symptoms. Minimum to Maximum values: 0-100. Higher scores represent better outcome.
Time Frame
KCCQ at 3 months
Title
Patient report of HF symptoms
Description
Kansas City Cardiomyopathy Questionnaire (KCCQ) will assess patient report of symptoms. Minimum to Maximum values: 0-100. Higher scores represent better outcome.
Time Frame
KCCQ at 6 months
Title
Patient report of eating habit self efficacy
Description
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.
Time Frame
Eating Habits at Baseline
Title
Patient report of eating habit self efficacy
Description
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.
Time Frame
Eating Habits at 3 months
Title
Patient report of eating habit self efficacy
Description
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.
Time Frame
Eating Habits at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francene Steinberg, PhD
Phone
530 752 0160
Email
fmsteinberg@ucdavis.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Brooke Wickman, MS
Email
bewickman@ucdavis.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francene Steinberg, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Health Center - Cardiology Department
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francene M Steinberg, PhD, RD
Phone
530-752-0160
Email
fmsteinberg@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Camryn Sellers-Porter, BS
Email
cmsellers@ucdavis.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
DASH Diet in Heart Failure Outpatients
We'll reach out to this number within 24 hrs