Effect of DASH Eating Pattern on Heart Failure Outcomes

NCT03538990 | Unknown

• 1 other identifier: STUDY00005216
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure NYHA Class III

Keywords

Nutrition; Dietary Approaches to Stop Hypertension; Cardiometabolic Outcomes; Pulmonary Artery Pressure; CardioMEMS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Functional Exercise Capacity between Calibration and DASH Diet Intervention Phase

  Baseline, week 3, week 6

Other Outcomes (2)

• Change in Inflammation Marker Levels between Calibration and DASH Diet Intervention Phase

  Baseline, week 3, week 6

• Change in Hemodynamic Marker Levels between Calibration and DASH Diet Intervention Phase

  week 1-3, week 3-6

Study Arms (1)

DASH Eating Pattern

EXPERIMENTAL

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

Interventions

DASH Eating Pattern OTHER

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.

DASH Eating Pattern

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Georgia: lead
• Emory University: collaborator

Study Sites (1)

University of Georgia Clinical and Translational Research Unit

Athens, Georgia, 30606, United States

RECRUITING

Study Officials

• Elisabeth L Sattler, PhD, BSPharm

  University of Georgia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabeth L Sattler, PhD, BSPharm

CONTACT

706-542-1040; lilian@uga.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 29, 2018
• Study Start: November 15, 2018
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 16, 2018

Record last verified: 2018-11

Locations

US (1)