跳至主要内容
临床试验/NCT04395846
NCT04395846进行中(未招募)不适用

Heart Failure and Preserved Ejection Fraction: Observation of Its Progression and Prognosis (HOPP-BERN)

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2020年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
350
试验地点
1
主要终点
Incidence of major adverse cardiovascular events (MACE)

研究概览

简要总结

Analysis of longitudinal data, cardiovascular magnetic resonance (CMR) imaging and health related data, of patients with heart failure and preserved ejection fraction (HFpEF) over a timeframe of 5 years per patient.

In this study routine clinical data are collected along with additional research parameters measured during CMR. CMR will occur throughout a 5-year follow-up.

详细描述

Heart Failure with Preserved Ejection Fraction (HFpEF) is becoming increasingly prevalent, yet diagnostics, characterization and prognosis of the disease is still uncertain. Multiple contributing factors have been implicated in the development of HFpEF such as but not limited to myocardial fibrosis, myocardial edema, ventricular remodeling, metabolic dysfunction, coronary microvascular dysfunction, ischemia, systemic effects and associated ventricular-arterial coupling. However, how the longitudinal progression of these factors is associated with HFpEF and whether a causal effect between the pathologic features in HFpEF exist, is not fully understood.

Using cardiovascular magnetic resonance (CMR), multiple cardiac and extracardiac parameters can be investigated in a single non-invasive imaging exam. This will be a single-centre prospective observational longitudinal study with the formation of a database. Patients will undergo a comprehensive CMR exam upon recruitment, 1- and 5-years after enrolment, and also if re-hospitalisation for heart failure occurs. This exam will investigate multiple measures of cardiovascular function, myocardial deformation, edema, fibrosis and oxygenation, 4D haemodynamical assessments, along with measurements of the aorta, liver and spleen. Furthermore, clinical data will be collected for the patients for the creation of a HFpEF database (ie. patient characteristics, Kansas City Cardiomyopathy Questionnaire (KCCQ), HF and risk scores, laboratory biomarkers, diagnostic results). With this study, the investigator will be able to quantify longitudinal changes in CMR features within the HFpEF population, and investigate what features are associated with poor prognosis. The data collected will lead to a greater understanding of HFpEF, and hopefully show which clinical or imaging features can be used to identify, and better risk stratify this heterogenous population.

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

  • Known Heart Failure with Preserved Ejection Fraction (HFpEF) (based on invasive measurement) or high probability of HFpEF (>70% based on H2FPEF score ≥4)
  • Ability to provide informed consent (knowledge of project languages), >18 years

排除标准

  • MRI incompatibility (ie. pacemakers, ICD, internal defibrillators)
  • Acute myocardial infarction (<90 days)
  • Recent cardiovascular surgery or intervention (<90 days)
  • Severe valve disease
  • Known infiltrative diseases (i.e. amyloidosis, sarcoidosis)
  • Known hypertrophic cardiomyopathy)
  • ARVC (arrhythmogenic right ventricular cardiomyopathy), non-compaction cardiomyopathy
  • Heart transplant
  • Treatment for chemotherapy or radiotherapy
  • Pregnancy

结局指标

主要结局

Incidence of major adverse cardiovascular events (MACE)

时间窗: Within 5 years

Composite outcome = the first occurrence of hospitalization for heart failure or all-cause mortality.

次要结局

  • Incidence of adverse clinical events(Within 5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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