Effect of Dietary Approaches to Stop Hypertension Eating Pattern on Cardiometabolic Markers in Advanced Heart Failure Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in Cardiometabolic Marker Levels between Calibration and DASH Diet Intervention Phase
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Cardiometabolic Marker Levels between Calibration and DASH Diet Intervention Phase
时间窗: 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).
次要结局
- Change in Functional Exercise Capacity between Calibration and DASH Diet Intervention Phase(Baseline, week 3, week 6)
研究者
Elisabeth Lilian Pia Sattler, Ph.D., B.S. Pharm
Assistant Professor
University of Georgia