| CTRI Number |
CTRI/2025/12/098349 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Heart problem in liver disease and its effect after living donor liver transplant |
|
Scientific Title of Study
|
Prevalence of cirrhotic cardiomyopathy and its implications in patients undergoing living donor liver transplantation - A prospective observational 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 |
Nisha Maharu M G |
| Designation |
Associate consultant |
| Affiliation |
Institute |
| Address |
Dr Rela Institute and
Medical center
7 CLC work road
Nagappa nagar
Chromepet
Chennai
Dr Rela Institute and
Medical center
7 CLC work road
Nagappa nagar
Chromepet
Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
09994107950 |
| Fax |
|
| Email |
nishamaharu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nisha Maharu M G |
| Designation |
Associate consultant |
| Affiliation |
Dr. Rela Institute and Medical centre |
| Address |
Dr Rela Institute and
Medical center
7 CLC work road
Nagappa nagar
Chromepet
Chennai
7 CLC work road
Nagappa nagar
Chromepet
Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
09994107950 |
| Fax |
|
| Email |
nishamaharu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nisha Maharu M G |
| Designation |
Associate consultant |
| Affiliation |
Institute |
| Address |
Dr Rela Institute and
Medical center
7 CLC work road
Nagappa nagar
Chromepet
Chennai
Dr Rela Institute and
Medical center
7 CLC work road
Nagappa nagar
Chromepet
Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
09994107950 |
| Fax |
|
| Email |
nishamaharu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Mohamed Rela |
| Address |
Dr Rela Institute and Medical center 7 CLC work road Nagappa nagar Chromepet Chennai
Dr Rela Institute and Medical center 7 CLC work road Nagappa nagar Chromepet Chennai
Chennai
TAMIL NADU
600044
India |
| Type of Sponsor |
Research institution |
|
|
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 |
| Nisha Maharu M G |
Dr. Rela institute and medical centre |
Department of liver anaesthesiology and critical care
Chennai
TAMIL NADU |
09994107950
nishamaharu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Rela Institute & Medical Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K77||Liver disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients between 18 to 65 years of age who are undergoing living donor liver transplant surgery at our institution |
|
| ExclusionCriteria |
| Details |
Patient refusal
Diagnosed with known cardiac disease - ischaemic heart disease, valvular or structural heart disease
Acute liver failure
Chronic kidney disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Will assess the status of cirrhotic cardiomyopathy
during peri operative period |
1 week, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Will analyse any other cardiac events |
1 week, 3 month & 6 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
20/01/2026 |
| 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="1"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Liver transplant is the definitive treatment for patients with end stage liver disease Due to altered physiological condition patients with cirrhosis develop a phenomenon called cirrhotic cardiomyopathy Cirrhotic cardiomyopathy is defined as cardiac dysfunction in patients with cirrhosis in the absence of prior cardiac disease In 2019 the cirrhotic cardiomyopathy consortium criteria reviewed electrophysiological changes in cirrhotic cardiomyopathy and discussed their clinical relevance and potential treatment strategies Systolic dysfunction like left ventricular ejection fraction less than or equal to fifty percentage or absolute global longitudinal strain less than 18 Advanced diastolic dysfunction with three or more like Septal e velocity of less than 7 E by e prime ratio of more than or equal to 15 Left atrial volume index of more than 34 Tricuspid regurgitation velocity of more than 2.8 Along with these other condition like any changes in electrocardiography or electromechanical uncoupling or serum biomarkers All these will be analysed by trans thoracic echocardiography in pre anaesthesia checkup and during post operative period Cardiac changes will be analysed and any cardiac events will be noted |