DASH Diet in Heart Failure Outpatients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: DASH diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm pragmatic trial with pre- and post- assessments
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary Intervention Arm<br>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<br>* Nutrition education and counseling on DASH diet, behavioral and lifestyle modifications<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Failure clinical marker | proBNP will be assessed as a marker of severity of heart failure | proBNP at baseline | 
| Heart Failure clinical marker | proBNP will be assessed as a marker of severity of heart failure | proBNP at 3 months | 
| Heart Failure clinical marker | proBNP will be assessed as a marker of severity of heart failure | proBNP at 6 months | 
| 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. | KCCQ at baseline | 
| 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. | KCCQ at 3 months | 
| 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. | KCCQ at 6 months | 
| 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. | Eating Habits at Baseline | 
| 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. | Eating Habits at 3 months | 
| 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. | Eating Habits at 6 months |