| CTRI Number |
CTRI/2024/08/072160 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Heart function assessment in chronic liver disease patients |
|
Scientific Title of Study
|
Cardiac Functions and Clinical Outcomes in Patients with Chronic Liver Disease: A Cohort Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M Swathi Poojary |
| Designation |
Assistant Professor |
| Affiliation |
MCHP,MAHE |
| Address |
Department of CVT,MCHP,MAHE,Manipal
Udupi
KARNATAKA
576113
India |
| Phone |
9740631887 |
| Fax |
|
| Email |
m.swathi@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishnananda Nayak |
| Designation |
Additional Professor & HOD |
| Affiliation |
MCHP, MAHE |
| Address |
Department of CVT,MCHP,MAHE,Manipal
Udupi
KARNATAKA
576113
India |
| Phone |
9964015487 |
| Fax |
|
| Email |
krishnananda.n@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
M Swathi Poojary |
| Designation |
Assistant Professor |
| Affiliation |
MCHP,MAHE |
| Address |
Department of CVT,MCHP,MAHE,Manipal
KARNATAKA
576113
India |
| Phone |
9740631887 |
| Fax |
|
| Email |
m.swathi@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Room No 36 3rd Floor OPD Block Department of Cardiology ,Kasturba Medical College ,Manipal,Karnataka,India,576113
Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
Department of cardiology |
| Address |
Kasturba Medical College and Hospital, MAHE, Manipal,Karnataka,India 576113 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Krishnananda Nayak |
Kasturba Hospital |
Room No 36 3rd Floor
OPD Bolck Department
of Cardiology Kasturba
hospital Manipal Udupi
KARNATAKA
576113
Udupi
KARNATAKA |
9964015487
krishnananda.n@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hopsital Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K740||Hepatic fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 30 to 70 years with Chronic Liver disease with
Child-Pugh classification A, B, and C.
|
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
4D-EF(%),4D-EDV(ml),4D-ESV(ml)
4D- GLS(%)
2D-LARS (%),RV FWS(%)
E/e’
LA volume Index(ml/mm2)
Pulmonary artery stiffness(KHz/sec)
Prevalence of LV dysfunction among Child-Pugh
classification A, B &C |
At the recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mortality
MACE
Cardiac arrhythmia
Refractory ascites
Liver transplantation
Hepatorenal syndrome
Bleeding
Pulmonary hypertension |
At the recruitment |
|
|
Target Sample Size
|
Total Sample Size="169"
Sample Size from India="169"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |