Multi-scale Phenotyping of Heart Failure: From Precision Phenotyping to Population Inference (PHENO-HEART)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- To study the association between multi-omics signatures with all-cause mortality
研究概览
简要总结
Background:
More than 6.5 million people in the United States live with heart failure (HF), and more than a million new cases are diagnosed each year. Treatments have improved in recent years, but researchers want to understand more about how HF develops. To do this, they need to compare blood and other samples from many people with HF.
Objective:
To collect blood and other samples from people with HF. These samples will be used to identify and study proteins and other factors that may lead to decreased heart function over time.
Eligibility:
People aged 18 years and older with heart failure.
Design:
Participants will be asked to join the study based on a review of their medical records.
They will have 1 study visit. They will provide a blood sample: About 3 tablespoons will be collected from a needle inserted into a vein.
Other tests are optional: Participants may provide urine and stool samples. They may have a cotton swab rubbed on the inside of the mouth to collect DNA.
Participants may also take 3 questionnaires. They will answer questions about dietary, social, and other factors that affect their health. Participants will receive compensation.
Researchers will follow the participants health by monitoring their medical records for up to 5 years.
详细描述
Study Description:
Our general hypothesis is that clinical and molecular data will generate new mechanistic knowledge and transform our understanding of the heterogeneous forms of heart failure (HF) syndrome. To do so, we will create a data-rich ecosystem by building a population-based registry. By grounding our work in the community within the District of Columbia / Maryland/Virginia metropolitan region (DMV), we will optimize inference and facilitate community translation. We will prospectively recruit a community cohort of 2000 participants with clinical HF from the DMV area and collect blood samples to measure multi-omics (specifically proteomics, metabolomics)signatures. We will integrate the results of the multi-omics assays to electronic medical records (EMR)-driven phenotypic representation (e.g., symptoms at clinical presentation, comorbid conditions, frailty, imaging data, ejection fraction, and laboratory values) collected during clinical care. Patients' records will be followed for up to 10 years after recruitment to monitor key characteristics and events, including death.
Objectives:
Primary Objective:
-To study the association between multi-omics signatures with all-cause mortality
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Clinical diagnosis of "active" HF documented by a cardiology provider's note in the medical record. Active HF is the presence of signs or symptoms that are deemed to be related to heart failure, as documented in the participants' medical records.
- •Able and willing to undergo the consent process and provide consent
- •Willing to comply with required study activities
- •18 years of age or older
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •History of ventricular assist device
- •History of cardiac transplant
- •Living or residing outside of the geographic location designated for the study at the time of enrollment
研究组 & 干预措施
Participants with heart condition
Heart Failure
结局指标
主要结局
To study the association between multi-omics signatures with all-cause mortality
时间窗: 10 years
The heterogeneous HF syndrome encompasses different and poorly defined entities. Multi-omics can improve its characterization and the prediction of mortality, which remains high. All-cause mortality will be analyzed as the time from enrollment to all-cause death.
次要结局
- Clinical phenotypes defined by:Ejection Fraction (>=50 vs. < 50)NYHA (3-4 vs. 1-2)(>=18 months vs. < 18 months)
- To study the cross-sectional association between multi-omics signatures with clinical sub-phenotypes of heart failure(5 years)