NCT04113291
撤回
不适用
Randomized Controlled Pilot Trial of Dietary Approached to Stop Hypertension (DASH) Feeding in Older Low Socioeconomic Adults Without Heart Failure
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Heart Failure
- 发起方
- Wake Forest University Health Sciences
- 试验地点
- 1
- 主要终点
- Number of enrolled participants per week
- 状态
- 撤回
- 最后更新
- 5年前
概览
简要总结
This is a study of the DASH diet (Dietary Approaches to Stop Hypertension) in the exploration of effective strategies for Heart failure (HF) with preserved ejection fraction (HFPEF) prevention.
详细描述
This is a feasibility pilot, randomized clinical trial (RCT), DASH diet feeding trial in 40 older adults. It will also elicit trends in left ventricular remodeling and pathophysiology. This trial investigates the feasibility of performing a DASH diet RCT intervention in HFPEF prevention in older adults of low socioeconomic status (LSES).
研究者
入排标准
入选标准
- •Participants will have an education level of less than college as a surrogate marker of LSES.
排除标准
- •Participants should not have a diagnosis of heart failure or loop diuretics on their medication list in the EHR or symptoms of dyspnea, edema (assessed via questionnaire)
- •poorly controlled diabetes mellitus ( HBA 1c \>9%)
- •or uncontrolled hypertension ( SBP\>180, DBP\>110)
- •cardiovascular event (MI, stroke, HF, angina, atrial fibrillation) within the previous six months
- •chronic diseases that might interfere with participation (dementia, schizophrenia, dialysis or transplant recipient patients)
- •body-mass index (the weight in kilograms divided by the square of the height in meters) of more than 35
结局指标
主要结局
Number of enrolled participants per week
时间窗: Up to week 12
Proportion of participants that adhere to the to intervention
时间窗: Up to week 12
Number participants that were retained in the trial
时间窗: Up to week 12
次要结局
- Proportion of participants that adhere to the diet(Up to week 12)
研究点 (1)
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