| CTRI Number |
CTRI/2026/02/103108 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of heart rhythm changes and their relation to disease severity in patients with liver cirrhosis |
|
Scientific Title of Study
|
QT prolongation and relation to severity in cirrhotics |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sankalp Gyani |
| Designation |
GEC Registrar |
| Affiliation |
Kasturba Medical College, Manipal, MAHE |
| Address |
Department of Gastroenterology and Hepatology, Old OPD block, 4th floor, Kasturba Medical College, Manipal, MAHE, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
7979924371 |
| Fax |
|
| Email |
sankalp.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Shiran Shetty |
| Designation |
Professor and Unit Head |
| Affiliation |
Kasturba Medical College, Manipal, MAHE |
| Address |
Department of Gastroenterology and Hepatology, Old OPD block, 4th floor, Kasturba Medical College, Manipal, MAHE, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8861920517 |
| Fax |
|
| Email |
drshiran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sankalp Gyani |
| Designation |
GEC Registrar |
| Affiliation |
Kasturba Medical College, Manipal, MAHE |
| Address |
Department of Gastroenterology and Hepatology, Old OPD block, 4th floor, Kasturba Medical College, Manipal, MAHE, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
7979924371 |
| Fax |
|
| Email |
sankalp.kmcmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sankalp Gyani |
| Address |
Department of Gastroenterology and Hepatology, Old OPD block, 4th floor, Kasturba Medical College, Manipal, MAHE, Karnataka, India 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sankalp Gyani |
Kasturba Medical College, Manipal |
Department of Gastroenterology and Hepatology, Old OPD block, 4th floor, Kasturba Medical College, Manipal, MAHE, Karnataka, India, 576104
Udupi
KARNATAKA |
7979924371
sankalp.kmcmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital IEC |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Liver cirrhosis |
|
| ExclusionCriteria |
| Details |
Cirrhotic with known cardiomyopathy
Patients with baseline electrolyte abnormalities
Patients on drugs that affect QT interval |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To look for the direct relationship between QT prolongation and severity in cirrhosis |
At baseline, 4 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To use this information in risk stratification & management of cirrhotic patients |
At baseline, 4 weeks & 8 weeks |
|
|
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)
|
25/02/2026 |
| 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="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
|
Title
QT prolongation and relation to severity in cirrhosis
Study type
Retrospective study
Aim
To evaluate the relationship between QT prolongation and Child Turcotte Pugh
score in patients with cirrhosis
Rationale
QT prolongation is common in cirrhosis with a reported prevalence of 30 to 70
percent
QT interval increases with worsening Child Pugh class
Prolonged QT is associated with ventricular arrhythmias sudden cardiac death
and reduced survival
Since ECG is routinely performed QT interval may serve as a simple non invasive
and cost effective marker of disease severity
Methods
Sample size 200 patients
Departments involved Gastroenterology Hepatology and Cardiology
Study duration 12 months
Inclusion criteria Age more than 18 years diagnosed cirrhosis
Exclusion criteria Known cardiomyopathy electrolyte abnormalities drugs
affecting QT interval
Procedure Routine ECG QT corrected using Bazett formula Correlation of QT with
Child Pugh score
Statistical analysis Descriptive and analytical statistics using SPSS Binary
logistic regression
Outcomes
Primary outcome Relationship between QT prolongation and severity of cirrhosis
Secondary outcome Use of QT prolongation for risk stratification and management
Ethics and risk
Minimal risk Written informed consent Confidentiality maintained
Budget
20000 rupees for ECG expenses
|