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CTRI Number  CTRI/2026/04/108850 [Registered on: 21/04/2026] Trial Registered Prospectively
Last Modified On: 10/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Prevalance of Cardio-hepatic syndrome in heart failure patients 
Scientific Title of Study   An exploratory study to assess the prevalence and associated factors of cardio-hepatic syndrome among patients with heart failure seeking treatment at heart failure clinic, aiims, new delhi with a view to develop a standard operating procedure (sop) for nursing care of patients with cardio-hepatic syndrome. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shri Kishan 
Designation  M.Sc. Nursing student 
Affiliation  AIIMS,New Delhi 
Address  Porta Cabin, Second floor, College of Nursing, AIIMS,New Delhi 110074

South
DELHI
110029
India 
Phone  9414413683  
Fax    
Email  shrikishanchaudhary@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tarika Sharma 
Designation  Associate Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no 4, Porta Cabin,2nd floor, college of Nursing, AIIMS New Delhi, 110074

South
DELHI
110029
India 
Phone  8219228244  
Fax    
Email  tarikasharma91@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shri Kishan 
Designation  M.Sc. Nursing student 
Affiliation  AIIMS, New Delhi 
Address  Porta Cabin, Second floor, College of Nursing, AIIMS,New Delhi 110029

South
DELHI
110029
India 
Phone  9414413683  
Fax    
Email  shrikishanchaudhary@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Shri Kishan 
Address  room no 05,second floor, College of Nursing, AIIMS,New Delhi, 110029 India 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tarika Sharma  AIIMS, New Delhi 110029, India  Cardiology OPD, Room No- 4, Heart Failure Clinic, New Delhi 110029,India
South
DELHI 		 8219228244

shrikishanchaudhary@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH, AIIMS, NEW DELHI 110029  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I50||Heart failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Who underwent liver function test recently (with in three months)

Willing to participate in the study.

Can understand hindi or english.

 
 
ExclusionCriteria 
Details  Patients with heart failure who are hemodynamically unstable.

Patients with heart failure who are admitted to the in patient department.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find the prevalence of cardio-hepatic syndrome among patients with heart failure seeking treatment at heart failure clinic, aiims, new delhi.  one time at the time of data collection 
 
Secondary Outcome  
Outcome  TimePoints 
1.To determine the factors associated with cardio-hepatic syndrome among patients with heart failure seeking treatment at heart failure clinic, aiims, new delhi.

2.To develop a standard operating procedure for nursing care of patients with cardio hepatic syndrome based on evidence generated through study findings.
 		 one time during the time of data collection 
 
Target Sample Size   Total Sample Size="264"
Sample Size from India="264" 
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)   10/08/2026 
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="0"
Months="5"
Days="0" 
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  

Background:

Heart failure (hf) is a chronic, progressive clinical syndrome and a major global public health problem, affecting an estimated 55–64 million people worldwide. It is associated with high rates of hospitalization, reduced quality of life, and substantial mortality, with nearly 50% of patients dying within five years of diagnosis. The burden of heart failure is rapidly increasing due to population ageing, improved survival after acute cardiac events, and rising prevalence of risk factors such as hypertension, diabetes mellitus, obesity, and ischemic heart disease.
Purpose of the study
1.To find the prevalence of cardio-hepatic syndrome among patients with heart failure seeking treatment at heart failure clinic, aiims, new delhi.

Secondary purpose -                        

1.  To determine the factors associated with cardio-hepatic syndrome among patients with heart failure seeking treatment at heart failure clinic, aiims, new delhi.

2.  To develop a standard operating procedure for nursing care of patients with cardio hepatic syndrome based on evidence generated through study findings.

 
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