Heart Failure NYHA Class III
Conditions
Keywords
Nutrition, Dietary Approaches to Stop Hypertension, Cardiometabolic Outcomes, Pulmonary Artery Pressure, CardioMEMS
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.
Interventions
OTHERDASH 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.
Sponsors
Emory University
University of Georgia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Inflammation Marker Levels between Calibration and DASH Diet Intervention Phase | Baseline, week 3, week 6 | 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). |
| Change in Hemodynamic Marker Levels between Calibration and DASH Diet Intervention Phase | week 1-3, week 3-6 | 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. |
Countries
United States
Contacts
Primary ContactElisabeth L Sattler, PhD, BSPharm
Outcome results
None listed