Longitudinal Gut Microbiome and Host Multi-omic Profiling in Patients With Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Temporal changes in the gut microbiome community composition in chronic heart failure
研究概览
简要总结
The goal of this observational study is to learn about the composition and function of the gut microbiome in adults with chronic heart failure with reduced ejection fraction. The main questions the study aims to answer are:
- How does the gut microbiome and its interactions with the host change over time in adults with chronic heart failure?
- How do these changes relate to heart failure disease severity and complications?
详细描述
During this study, investigators will recruit adults diagnosed with chronic heart failure with reduced ejection fraction caused by non-ischemic cardiomyopathy. These individuals will undergo longitudinal profiling. This will include detailed profiling of their (1) gut microbiome, (2) blood metabolic and immune markers, and (3) heart failure clinical status. Integrated results will lead to deeper understanding of how gut microbiome interacts with and affects the host in chronic heart failure.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart failure with reduced ejection fraction (left ventricular ejection fraction less than 50%)
- •Non-ischemic cardiomyopathy
- •Body mass index (BMI) 18-40 kg/m2
排除标准
- •Treated diabetes
- •Advanced kidney disease
- •Cirrhosis
- •Significant gastrointestinal disease including any history of inflammatory bowel disease
- •History of extensive bowel resection
- •Active malignancy or systemic chemotherapy within the past 12 months
- •Active infection
- •Current or recent (within 4 weeks) use of systemic antibiotics, commercial probiotics, immunosuppressive or immunomodulatory medications
- •Pregnancy/lactation
结局指标
主要结局
Temporal changes in the gut microbiome community composition in chronic heart failure
时间窗: 12 months from baseline visit
Longitudinal changes in the gut microbiome composition and functionality in chronic heart failure will be determined. Microbiome signatures will be mapped from fecal samples collected every 3 months over a 12 month period, generated from shotgun metagenomic sequencing data and after processing through bioinformatic pipelines.
Advanced heart failure-associated microbiome signatures
时间窗: 24 months from baseline visit
A map of gut microbiome compositional and functional features associated with a composite clinical outcome of advanced heart failure (composite of needing heart transplantation (including active listing), left ventricular assist device implantation, transition to hospice, or death) that occurs within 24 months of baseline visit. Fecal samples will be collected every 3 months over the first 12 month period. Microbiota composition will be determined by shotgun metagenomic sequencing, with taxonomic and metabolic pathway signatures generated using bioinformatic pipelines, respectively. Comprehensive microbiome signatures will encompass alpha and beta diversity, and differential abundance analysis.
次要结局
- Comprehensive longitudinal metabolome profile in chronic heart failure(12 months from baseline visit)
- Longitudinal change in the self-reported functional status(12 months from baseline visit)
- Comprehensive longitudinal cytokine profile in chronic heart failure(12 months from baseline visit)
- Longitudinal change in New York Heart Association (NYHA) functional class(12 months from baseline visit)
研究者
Petra Mamic
Instructor
Stanford University