Heart Failure NYHA Class III Clinical Trial
— DASH HFOfficial title:
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.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | December 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Georgia Clinical and Translational Research Unit | Athens | Georgia |
Lead Sponsor | Collaborator |
---|---|
University of Georgia | Emory University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | 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 | |
Primary | 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 | 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 |
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