跳至主要内容
临床试验/CTRI/2024/08/072160
CTRI/2024/08/072160尚未招募不适用

Cardiac Functions and Clinical Outcomes in Patients with Chronic Liver Disease: A Cohort Study

Department of cardiology1 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2024年8月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
169
试验地点
1
主要终点
4D-EF(%),4D-EDV(ml),4D-ESV(ml)

研究概览

简要总结

After IEC clearance and CTRI registration, this prospective observational study will be conducted. Chronic liver disease patients advised cardiac evaluation at Kasturba Hospital, Manipal, will be enrolled in this study. Cases are selected if willing to give informed consent.12 lead ECGs will be recorded. ECG Gated 4D Echocardiography, along with Conventional and Strain echocardiography (layer-specific strain)) will be performed and recorded. Strain echocardiographic analysis will be performed offline with the already available recorded echo images and stored for future reference. LVEF, RV parameters, strain, and strain rate will be measured at baseline. Standard views will be taken with the patient lying in the left lateral decubitus position. Standard views were recorded and stored, i.e., the parasternal long axis and short axis at three levels of LV and the apical 4,5,3 and 2 chamber views. LVEF measurements will be taken using M mode and Simpson’s method. These images will be stored for offline analysis of strain. The study will be continued and performed at six months of follow-up. A reminder call will be given to the patients for follow-up. The follow-up data will be collected, and all the parameters will be reassessed at six months of Follow-up. Till the study duration, all the clinical outcomes will be followed up

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 30 to 70 years with Chronic Liver disease with Child-Pugh classification A, B, and C.

排除标准

  • History of Valvular heart disease(moderate-severe) History of Ischemic heart disease History of Congenital heart disease Cardiomyopathy Atrial fibrillation Post cardiac surgery Poor Echo Window.

结局指标

主要结局

4D-EF(%),4D-EDV(ml),4D-ESV(ml)

时间窗: At the recruitment

4D- GLS(%)

时间窗: At the recruitment

2D-LARS (%),RV FWS(%)

时间窗: At the recruitment

E/e’

时间窗: At the recruitment

LA volume Index(ml/mm2)

时间窗: At the recruitment

Pulmonary artery stiffness(KHz/sec)

时间窗: At the recruitment

Prevalence of LV dysfunction among Child-Pugh

时间窗: At the recruitment

classification A, B &C

时间窗: At the recruitment

次要结局

  • Mortality(MACE)

研究者

发起方
Department of cardiology
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

M Swathi Poojary

MCHP,MAHE

研究点 (1)

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