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Clinical Trials/CTRI/2024/08/072160
CTRI/2024/08/072160
Not yet recruiting
Not Applicable

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

Department of cardiology1 site in 1 country169 target enrollmentStarted: August 20, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Department of cardiology
Enrollment
169
Locations
1
Primary Endpoint
4D-EF(%),4D-EDV(ml),4D-ESV(ml)

Overview

Brief Summary

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

Study Design

Study Type
Observational

Eligibility Criteria

Ages
30.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

Time Frame: At the recruitment

4D- GLS(%)

Time Frame: At the recruitment

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

Time Frame: At the recruitment

E/e’

Time Frame: At the recruitment

LA volume Index(ml/mm2)

Time Frame: At the recruitment

Pulmonary artery stiffness(KHz/sec)

Time Frame: At the recruitment

Prevalence of LV dysfunction among Child-Pugh

Time Frame: At the recruitment

classification A, B &C

Time Frame: At the recruitment

Secondary Outcomes

  • Mortality(MACE)

Investigators

Sponsor
Department of cardiology
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

M Swathi Poojary

MCHP,MAHE

Study Sites (1)

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