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临床试验/NCT05383287
NCT05383287招募中不适用

Characteristics, Phenotypes, and TRAITS of Heart Failure With Preserved Ejection Fraction (TRAITS-HFpEF)

Manchester University NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 1,250 人开始时间: 2022年8月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,250
试验地点
1
主要终点
Composite of all cause mortality and hospitalisation for heart failure

研究概览

简要总结

Heart failure with preserved ejection fraction (HFpEF), a certain type of heart failure, occurs when the heart doesn't pump blood around the body properly. It can cause breathlessness, tiredness, and swollen feet or ankles. It is not clear why people develop HFpEF and treatment options are very limited.

TRAITS-HFpEF is a study that aims to understand why people develop HFpEF, identify new tests and treatments, and gain information on the life expectancy of people living with this condition. It will do this by routinely collecting information on people attending a specialised outpatient HFpEF clinic.

详细描述

HFpEF represents the single largest unmet need in cardiovascular medicine (Butler et al, 2014). The proportion of patients with HFpEF ranges from 22 to 73% of all heart failure patients across all clinical settings, including primary care, hospital care and hospital admission (Ponikowski et al, 2016).

Treatment options in HFpEF are very limited, and several clinical trials have demonstrated neutral results when assessing survival benefit from medical therapy. A common theme for this is the heterogeneity that exists in the HFpEF patient population and non-targeted therapy is inadequate for this diverse population. Patients need to be characterised according to their clinical phenotypes and underlying biological mechanisms in order to provide targeted patient-specific treatment. (Shah et al, 2016)

TRAITS-HFpEF is an observational cohort study that aims to assess the epidemiology, and the association of clinical variables and outcomes of patients with HFpEF. A dedicated specialist HFpEF clinic provides the opportunity to recruit and collect data on a large cohort of patients that can provide insights into different HFpEF phenotypes and their associations and outcomes. This can help direct future research and delivery of specialist care.

All patients attending the HFpEF clinic at Manchester University NHS Foundation Trust (MFT) will be approached. The expectation is to recruit approximately 1,250 patients over a 5-year period. With the patients consent, a blood sample of approximately 10mL will be taken for biobanking to allow measurement of yet to be identified biomarkers, including plasma and DNA. This will be optional for patients. All clinical variables will be documented at the time of the recruitment.

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

  • Patients attending the HFpEF clinic at MFT.

排除标准

  • Age < 18 years
  • Imprisonment
  • Inability to provide full written or verbal informed consent in English

结局指标

主要结局

Composite of all cause mortality and hospitalisation for heart failure

时间窗: 7.5 years

次要结局

  • Hospitalisation for heart failure(7.5 years)
  • All cause mortality(7.5 years)
  • Identification of HFpEF phenotypes(7.5 years)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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