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| Name | Class |
|---|---|
| Emory University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisabeth L Sattler, PhD, BSPharm | Contact | 706-542-1040 | lilian@uga.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elisabeth L Sattler, PhD, BSPharm | University of Georgia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Georgia Clinical and Translational Research Unit | Recruiting | Athens | Georgia | 30606 | United States |
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| 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 |