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临床试验/NCT06228807
NCT06228807已完成不适用

Exploring Clinical Characteristics and Predictors of Adverse Outcomes in Patients Diagnosed With Heart Failure With Preserve Ejection Fraction (HFpEF)

Ya-Wei Xu0 个研究点目标入组 584 人开始时间: 2015年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
584
主要终点
Composite Events

研究概览

简要总结

Heart failure with preserved ejection fraction (HFpEF) is a prevalent form of heart failure characterized by impaired left ventricle pressures and diastolic dysfunction. Despite its increasing prevalence, effective treatment options for HFpEF remain limited, probably due to its heterogenous underlying pathological etiology involving chronic systemic inflammation and metabolic dysregulation. Identifying new predictors of poor prognosis is crucial for risk stratification and tailored management.

详细描述

The prognosis for HFpEF is concerning, marked by significant mortality and frequent hospital readmissions. The exact mechanisms underlying HFpEF remain unresolved. The clinical syndrome arises from intricate interactions among various risk factors, leading to organ dysfunction and clinical symptoms. Common co-morbidities, including atrial fibrillation, diabetes, chronic kidney disease, and obesity, may influence HFpEF pathophysiology. Recent discussions suggest an inflammatory-metabolic phenotype in HFpEF, characterized by heightened inflammatory biomarkers, insulin resistance, hyperglycemia, hyperlipidemia, microvascular endothelial and vascular dysfunction, atherosclerosis, consequently leading to significant myocardial damage. However, there is still a lack of clinical risk predictors associated with metabolic phenotype within HFpEF.

The aim of this study is to investigate the impact of parameters reflecting the metabolic phenotype, coronary microvascular dysfunction in HFpEF and establish their correlation with clinical outcomes. The objective is to identify novel predictors for adverse prognosis in HFpEF, potentially serving as targets for drug therapy. This research aims to pave the way for targeted drug interventions in cardiometabolic diseases, offering new avenues for therapeutic approaches.

研究设计

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

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 diagnosed with HFpEF; Diagnostic criteria for HFpEF
  • Presence of heart failure signs/symptoms symptoms
  • Preserved left ventricular ejection fraction (EF) ≥50%
  • BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL;
  • At least one additional criteria: presence of cardiac functional and structural abnormalities or diastolic dysfunction.

排除标准

  • LVEF lower than 50%
  • Patients with serious hepatic and renal failure,
  • Non-cardiac causes of dyspnea, such as, asthma
  • Primary pulmonary hypertension.
  • Severe valvular heart disease.
  • Pericardial disease.
  • Recent history of myocardial infarction.
  • Coronary artery disease (stenosis>50).
  • Reduced contrast opacification (for caIMR assessment).

结局指标

主要结局

Composite Events

时间窗: From the time of hospital discharge until the event of specific outcome, death, or loss to follow up, maximum 10 years.

The composite events include a composite of all-cause mortality (death due to any cause), cardiovascular mortality (death due to cardiac cause), and heart failure rehospitalization.

次要结局

未报告次要终点

研究者

发起方
Ya-Wei Xu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ya-Wei Xu

Chief Physician

Shanghai 10th People's Hospital

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