Effect of DASH Eating Pattern on Heart Failure Outcomes (DASH HF)

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

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 Overview

• Status: Unknown
• Conditions: Heart Failure NYHA Class III
• Intervention / Treatment: Other: DASH Eating Pattern

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Athens, Georgia, United States, 30606
      • Recruiting
      • University of Georgia Clinical and Translational Research Unit
      • Contact: Kimberly Schmitz, MS; Phone Number: 706-713-2721; Email: schmitzk@uga.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: DASH Eating Pattern; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Inflammation Marker Levels between Calibration and DASH Diet Intervention Phase	We will compare the change of the following inflammation marker values 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): interleukin (IL)-1a, IL-1b, IL-6, and tumor necrosis factor alpha (TNF-a).	Baseline, week 3, week 6
Change in Hemodynamic Marker Levels between Calibration and DASH Diet Intervention Phase	Change in mean hemodynamic marker levels will be calculated by comparing mean values from the calibration (week 1-3) and intervention phase (week 3-6). All patients will be instructed to take daily pulmonary artery pressure home readings for the duration of the study.	week 1-3, week 3-6

Collaborators and Investigators

• Sponsor: University of Georgia
• Collaborators: Emory University
• Investigators: Principal Investigator: Elisabeth L Sattler, PhD, BSPharm, University of Georgia

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 15, 2018
• Primary Completion (ANTICIPATED): September 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (ACTUAL): May 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2018
• Last Update Submitted That Met QC Criteria: November 14, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Nutrition; Pulmonary Artery Pressure; CardioMEMS; Dietary Approaches to Stop Hypertension; Cardiometabolic Outcomes
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: STUDY00005216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No