Effect of DASH Eating Pattern on Heart Failure Outcomes

Study Overview
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Brief Summary
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The objective of the study is to examine the effect of nutritional intake on cardiometabolic, inflammation, and physical function markers in advanced heart failure patients using a one-group pre-post test design feeding trial. Effects on hemodynamic markers will be assessed in a subsample of patients with implanted hemodynamic monitoring devices (CardioMEMS). The pre-test condition is represented by participants' self-selected diet, and the post-test condition is represented by a prescribed Dietary Approaches to Stop Hypertension (DASH) diet.

Official Title
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Effect of Dietary Approaches to Stop Hypertension Eating Pattern on Cardiometabolic Markers in Advanced Heart Failure Patients

Conditions
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Heart Failure NYHA Class III

Intervention / Treatment
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* Other: DASH Eating Pattern


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18+ years of age English language literacy Diagnosis of HF ≥ 3 months Diagnosis of NYHA Class III HF (historical assessment) Subjects must be stable on HF medication regimen for one month prior to study entry At least 1 HF hospitalization within 24 months of enrollment BNP >200 pg/ml Exclusion Criteria: Subjects who have had an unplanned HF-related hospitalization within 2 months of enrollment Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min who are nonresponsive to diuretic therapy or who are on chronic renal dialysis Subjects likely to undergo heart transplantation within 2 months of enrollment Subjects with severe conditions limiting 6-month survival Unavailability during scheduled data collection points Cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DASH Eating Pattern<br>The DASH eating pattern meals prepared for study participants will strictly follow DASH meal planning guidelines published by National Heart, Lung, and Blood Institute of the National Institutes of Health. During the intervention phase of the study, all participants will exclusively consume prepared meals and provided beverages which will be delivered to participants' homes. Meals will be planned and prepared based on individual participant energy needs and dietary restrictions by a Registered Dietitian at the Georgia Clinical and Translational Science Alliance (CTSA) Bionutrition Unit located at Emory University. | Other: DASH Eating Pattern<br>* The DASH diet is a heart-healthy eating pattern that is focused on adequate consumption of fruits, vegetables, whole grains, low-fat dairy, fish, poultry, beans, nuts, and vegetables oils while emphasizing limited intake of foods containing saturated fat, such as fatty red meats, full-fat dairy products, and tropical oils, such as coconut, palm kernel, and palm oils, as well as sugar-sweetened beverages and sweets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cardiometabolic Marker Levels between Calibration and DASH Diet Intervention Phase | Change of the following cardiometabolic marker values will be calculated between calibration and intervention phase using repeated measures analysis methods (3 time points over the course of 6 weeks: baseline, mid-point, post-DASH intervention): fasting lipid panel, hemoglobin A1c, basic metabolic panel (sodium, potassium, chloride, carbon dioxide (CO2), blood urea nitrogen, creatinine, and glucose), B-type natriuretic peptide (BNP), N terminal proBNP, troponin 1, mid-regional pro-adrenomedullin (MR-proADM), soluble somatostatin receptor 2 (sST2). | Baseline, week 3, week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Exercise Capacity between Calibration and DASH Diet Intervention Phase | We will compare the change in functional exercise capacity using the American Thoracic Society 6-minute walk test between calibration and intervention phase using repeated measures analysis methods (3 time points over the course of 6 weeks: baseline, mid-point, post-DASH intervention). | Baseline, week 3, week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition, Dietary Approaches to Stop Hypertension, Cardiometabolic Outcomes, Pulmonary Artery Pressure, CardioMEMS