NCT03409926已完成不适用
The Need for FibEr Addition in SympTomatic Heart Failure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 6
- 主要终点
- NT-proBNP
研究概览
简要总结
FEAST-HF is a single-centre clinical trial in ambulatory patients with chronic HF to evaluate whether dietary supplementation with acacia gum reduces HF-related biomarkers NT-proBNP and ST2 and how the gut microbiome responds to dietary supplementation with acacia gum. The hypotheses of this study are 1) that changes in the gut microbiome will be correlated with a reduction in NT-proBNP and ST2 in patients with HF after treatment with acacia gum, and 2) gut microbiome configurations (composition, diversity), stability and function (gene content) will be significantly altered in patients with HF in response to acacia gum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 or older
- •Willing and able to provide informed consent
- •Patients with established Heart Failure (as per their treating physician) including those with both reduced and preserved ejection fraction
排除标准
- •Patients requiring a special diet that would prohibit the intervention (e.g. celiac disease, irritable bowel disease)
- •Patients who do not control their own meals (e.g. meals-on-wheels, long-term care)
- •Patients with conditions that would interfere with the analysis of the microbiome (e.g. chronic diarrhea, recent antibiotics within the past month)
结局指标
主要结局
NT-proBNP
时间窗: 12 weeks
change in NT-proBNP level
次要结局
- ST-2(12 weeks)
- Composite Clinical Outcomes(12 weeks)
- 6-Minute Walk Test(12 weeks)
- NYHA Functional Class(12 weeks)
- Fecal Microbiome Characterization(Baseline, Week 6, Week 12)
- Quality of Life(12 weeks)
研究者
Justin Ezekowitz
Professor of Medicine
University of Alberta
研究点 (6)
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