临床试验/NCT03050593

NCT03050593已完成不适用

Prospective, Observational, Single-centre, Cohort Study Aimed at Developing Imaging and Plasma Biomarkers in Heart Failure With Preserved Ejection Fraction

University of Leicester0 个研究点目标入组 280 人开始时间: 2013年2月最近更新: 2017年2月13日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Leicester
入组人数: 280
主要终点: The composite end-point of all-cause mortality or repeat hospitalisation with heart failure

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The investigators wish to test a hypothesis that patients with HFpEF have different characteristics on echo, cardiac MRI and plasma protein & chemical profiles compared to HFrEF and healthy volunteers.

详细描述

Large scale prospective studies incorporating cardiac MRI, echocardiography and plasma sampling are currently lacking in HFpEF. The main aims of our study are to:

better phenotype and characterise HFpEF (also comparing with HFrEF and age- and sex- matched healthy controls)
provide mechanistic insights into pathophysiology
describe potential biomarkers and their relation to relevant clinical outcomes (exercise capacity, heart failure quality of life and prognosis)

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: 是

入选标准

•Clinical features of heart failure or prior radiographic evidence in the absence of symptoms And Either ejection fraction > 50% (for HFpEF arm) or ejection fraction < 40% (for HFrEF arm)

排除标准

•Myocardial infarction within the preceding 6 months
•Suspected or confirmed cardiomyopathy (e.g. hypertrophic, infiltrative)
•Suspected or confirmed constrictive pericarditis
•Significant native valve disease (≥ moderate severity)
•Known Significant lung disease (documented or FEV1< 30% or FVC < 50%)
•Non-cardiovascular co-morbidity likely to cause death within 6 months (e.g. malignancy)
•Significant renal failure (estimated GFR < 30 ml/min/m2)
•Patient inability to provide informed consent (e.g. dementia)

结局指标

主要结局

The composite end-point of all-cause mortality or repeat hospitalisation with heart failure

时间窗: Minimum 6 month follow-up

次要结局

Quality of life assessed by the Minnesota Living with Heart Failure Questionnaire(Through study completion, an average of 1 year)
The number of new clinical diagnoses detected by cardiac MRI(Through study completion, an average of 1 year)
Exercise capacity as assessed by the six-minute walk test(Through study completion, an average of 1 year)

研究者

发起方

University of Leicester

申办方类型

Other

责任方

Sponsor

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