Effect of DASH Eating Pattern on Heart Failure Outcomes

University of Georgia36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure NYHA Class III

Interventions

DASH Eating PatternOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 18+ years of age 2. English language literacy 3. Diagnosis of HF ≥ 3 months 4. Diagnosis of NYHA Class III HF (historical assessment) 5. Subjects must be stable on HF medication regimen for one month prior to study entry 6. At least 1 HF hospitalization within 24 months of enrollment 7. BNP \>200 pg/ml Exclusion Criteria: 1. Subjects who have had an unplanned HF-related hospitalization within 2 months of enrollment 2. Subjects with a Glomerular Filtration Rate (GFR) \<25 ml/min who are nonresponsive to diuretic therapy or who are on chronic renal dialysis 3. Subjects likely to undergo heart transplantation within 2 months of enrollment 4. Subjects with severe conditions limiting 6-month survival 5. Unavailability during scheduled data collection points 6. Cognitive impairment

Locations (1)

University of Georgia Clinical and Translational Research Unit

Athens, Georgia, United States

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: Baseline, week 3, week 6

Secondary Outcomes

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).

Time frame: Baseline, week 3, week 6

Central Contacts

Elisabeth L Sattler, PhD, BSPharm

CONTACT

706-542-1040 lilian@uga.edu

Data from ClinicalTrials.gov

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