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临床试验/NCT02728154
NCT02728154撤回不适用

Characterize the Gut Microbiota in Subjects With Heart Failure and Pre-heart Failure With Preserved Ejection Fraction

University of Florida1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
220
试验地点
1
主要终点
Stool sample for fecal microbiota between the groups

研究概览

简要总结

Gut microbiota play an important role in normal cardiovascular function and pathophysiology of cardiovascular diseases. Patients with heart failure (HF) have substantial hemodynamic changes which lead to intestinal hypoperfusion and congestion and eventually change gut morphology, permeability, function and composition of gut microbiota and cause translocation of microbial and endotoxins into the blood stream. Additionally, metabolites derived from gut microbiota modulate the pathophysiology of HF. Patients with HF have intestinal overgrowth of pathogenic bacteria and increased gut permeability. Accumulating evidence demonstrates that antibiotic treatment benefits patients with acute coronary syndromes and reduces the incidence of ischemic cardiovascular events. Taking the strong association of gut microbiota with HF into account, it is reasonable to speculate that gut microbiota could contribute to the progression of pre-HF with preserved ejection fraction (pre-HFpEF) to HF with preserved ejection fraction (HFpEF). Pre-HFpEF remains poorly understood, yet has high prevalence and a significantly high risk for death in comparison to patient without pre-HFpEF. We hypothesize that altered gut microbiota is involved in the initiation and establishment of HF and pre-HFpEF.

详细描述

The research study will initially enroll 50 subjects without HF as normal controls,120 subjects with history of HF and 50 subjects with pre-HFpEF to characterize gut microbiota. The subjects will provide blood samples and a stool sample.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Competent and willing to provide consent
  • Control subjects with normal heart function
  • Subjects with history of HF
  • Subjects with impaired ventricular relaxation and/or elevated left ventricular end diastolic pressure measured by echocardiography and/or catheterization, yet has not had HF clinical presentations

排除标准

  • intestinal surgery,
  • inflammatory bowel disease,
  • celiac disease,
  • lactose intolerance,
  • chronic pancreatitis or
  • other malabsorption disorder

结局指标

主要结局

Stool sample for fecal microbiota between the groups

时间窗: Day 1

Stool samples will be collected to compare the fecal microbiota of subjects with normal, diastolic heart dysfunction before heart failure developed and heart failure.

次要结局

  • Blood samples for inflammatory cytokines between the groups(Day 1)
  • Blood samples for inflammatory cells between the groups(Day 1)
  • Blood samples for SAA between the groups(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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