跳至主要内容
临床试验/NCT05573997
NCT05573997招募中不适用

Clinical Value of Novel Echocardiographic Biomarkers Assessing the Myocardial Work in Heart Failure

Aristotle University Of Thessaloniki1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年4月10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
300
试验地点
1
主要终点
Relationship between different heart failure sub-groups and echocardiographic indices

研究概览

简要总结

This study seeks to investigate the clinical value of novel echocardiographic indices, including myocardial work parameters, during the acute phase of heart failure hospitalization. The trajectory of novel echocardiographic indices from the start to the end of hospitalization will be captured, as a means to unravel and subsequently better understand the diverse pathophysiology of different phenotypes of the heart failure continuum. Correlation between novel echocardiographic indices with clinical data, biochemical data, different heart failure phenotypes, and therapeutic maneuvers will be attempted. Prognostic implications of those indices will be explored.

详细描述

Despite ongoing advances in early diagnosis and therapy, heart failure (HF) represents a worldwide health burden with high in-hospital mortality during the acute phase of hospitalization and high readmission rates following the event of decompensation. Patients acutely hospitalized for HF represent a widely heterogenous population in terms of primary etiology, clinical manifestations, echocardiographic characteristics, appropriate therapeutic management, and prognosis.

As more advanced HF therapeutic strategies are emerging, the cardiology community attempts to identify new HF sub-phenotypes that will serve as successful recipients of such treatments. The role of echocardiography in this attempt is far from exhausted, as novel indices are entering the research arena potentially capable of identifying new phenotypes, enlightening the subtending pathophysiology, and providing incremental prognostic information.

All adult patients acutely admitted at the Department of Cardiology at AHEPA University General Hospital of Thessaloniki with symptoms and/or signs of HF meeting the inclusion criteria will be invited to participate in the present study. A complete and comprehensive medical interview will be conducted in each eligible patient. Demographic characteristics and baseline medical history, including primary etiology and clinical presentation of hospitalization will be recorded for all participants. Pharmacological and non-pharmacological standard of care therapeutic maneuvers during the acute phase of hospitalization, as well as medical therapy upon admission and discharge will be collected. A comprehensive transthoracic echocardiographic assessment (TTE) including 2-dimensional-speckle-tracking analysis of all cardiac chambers, and non-invasive calculation of myocardial work of the left and right ventricle will be performed during hospitalization. The first TTE will be performed within 24 hours from admission, and the second within 24 hours pre-discharge, to capture the trajectory and net variations of all echocardiographic indices of interest. Blood samples for biochemical analysis, including N-terminal pro-B-type natriuretic peptide plasma concentrations will be collected upon admission and prior to discharge.

Through this prospective registry, association of novel echocardiographic indices and their net changes during hospitalization with clinical and biochemical data, diverse HF phenotypes, therapeutic maneuvers, and response to treatment will be attempted, as a means to explore the pathophysiology of different HF phenotypes and ultimately provide individualized acute HF management guidance. The clinical value and prognostic implications of those echocardiographic indices will be investigated during follow-up.

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 acutely admitted at the Department of Cardiology of AHEPA University General Hospital, Thessaloniki, Greece with symptoms and/or signs of heart failure (HF), as those are defined by the European Society of Cardiology.
  • Patients with abnormal plasma concentration of N-terminal pro-B-type natriuretic peptide, measured within 24 hours from admission
  • Objective echocardiographic evidence of cardiac structural and/or functional abnormalities consistent with the presence of left ventricular (LV) systolic dysfunction/diastolic dysfunction/raised LV filling pressures upon admission assessment

排除标准

  • Symptoms and/or signs of HF secondary to congenital heart disease, infective endocarditis, pericardial disease, and history of recent cardiac surgery (<1 month)
  • Patients receiving maintenance hemodialysis
  • Patients with active malignancy and/or life expectancy < 1 year
  • Poor echocardiographic acoustic windows precluding reliable assessment and/or analysis
  • Heart transplantation
  • Patients not providing informed written consent to participate in the study

结局指标

主要结局

Relationship between different heart failure sub-groups and echocardiographic indices

时间窗: 12 months

Conventional and novel echocardiographic parameters including among others left ventricular myocardial work indices, right ventricular myocardial work indices, 2-dimensional speckle-tracking analysis of all cardiac chambers.

次要结局

  • Prognostic factors in acute and chronic heart failure(12 months)
  • Relationship between clinical, laboratory, and echocardiographic biomarkers with short- and long-term prognosis of patients(12 months)
  • Relationship between therapeutic management of acute heart failure, laboratory profile, and net changes of echocardiographic indices(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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