Effect of DASH Eating Pattern on Heart Failure Outcomes
- Conditions
- Heart Failure NYHA Class III
- Interventions
- Other: DASH Eating Pattern
- Registration Number
- NCT03538990
- Lead Sponsor
- University of Georgia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 36
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DASH Eating Pattern 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.
- Primary Outcome Measures
Name Time Method Change in Cardiometabolic Marker Levels between Calibration and DASH Diet Intervention Phase Baseline, week 3, week 6 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).
- Secondary Outcome Measures
Name Time Method Change in Functional Exercise Capacity between Calibration and DASH Diet Intervention Phase Baseline, week 3, week 6 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).
Trial Locations
- Locations (1)
University of Georgia Clinical and Translational Research Unit
🇺🇸Athens, Georgia, United States