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临床试验/NCT07174362
NCT07174362招募中不适用

QUAD-HF Registry - A Prospective Registry of Patients With Incident Heart Failure and Left Ventricular Ejection Fraction of <50%

Mid and South Essex NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2025年10月6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
4,000
试验地点
2
主要终点
Cardiovascular Mortality or Hospitalization for Heart Failure

研究概览

简要总结

The QUAD-HF registry is an observational study that would enroll patients in the United Kingdom, who have been newly diagnosed with heart failure and a left ventricular ejection fraction <50%. We plan to assess clinical outcomes in these patients, such as hospitalization and death, in relation to their diagnosis, implementation of guidelines and type of treatments these patients have received.

详细描述

Heart failure (HF) is a widespread global health challenge, affecting approximately 1 million individuals in the United Kingdom and the prevalence is predicted to almost double in the next decades due to the ageing population. In the United Kingdom, hospitalizations for HF account for 5% of emergency medical admissions with a substantial economic burden.

The management of heart failure however is a true success story of modern medicine. Four decades of randomised clinical trials, provide the evidence base for an extensive catalogue of disease-modifying pharmacological and device treatments that have improved prognosis, particularly in patients with HF and a reduced LVEF <50%.

However, controlled studies tend to evaluate treatments in selected patient cohorts defined by strict trial inclusion criteria and often exclude older patients, include less women and patient background is often non-diverse. Furthermore, while within clinical trials these treatments are readily available and delivered to patients in meticulous and tightly controlled settings, this does not usually reflect real-world clinical environments, where there may be resource deficiencies. Indeed, a recent cross-sectional survey of hospital-based HF services in the UK, demonstrates wide variation in access to treatment and services. It is therefore important to evaluate the utilization of these treatments and adherence to practice guidelines in a real-world setting.

In England & Wales, a National Heart Failure Audit collects data in patients with HF who have unplanned hospitalisations for worsening symptoms. This does not extend outside of hospital settings, where the majority of patients time is spent managing their condition. The UK HFpEF study is an ongoing study which caters for patients who have heart failure with a preserved left ventricular ejection fraction (>50%).

There is however no readily available database or registry outside of hospital, that provides contemporaneous information about the care, changes in management or long-term outcomes for patients with HF and a left ventricular ejection fraction of <50%, as exists in other healthcare systems.

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

  • Age >18 years
  • Newly diagnosed Heart Failure with a Left Ventricular Ejection Fraction <50% (≤12 Weeks prior to enrolment).
  • Able and willing to consent.

排除标准

  • LVEF 50% or more at time of diagnosis
  • Palliative care
  • Unable or unwilling to give consent

结局指标

主要结局

Cardiovascular Mortality or Hospitalization for Heart Failure

时间窗: From enrolment to 12 months after diagnosis

Death due to cardiac causes or hospitalization due to worsening heart failure symptoms

次要结局

  • All-cause mortality(From enrolment to 12 months after diagnosis)
  • Cardiovascular Mortality(From enrolment to 12 months after diagnosis)
  • Hospitalization for Heart Failure(From enrolment to 12 months after diagnosis)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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