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CTRI Number  CTRI/2024/12/078464 [Registered on: 23/12/2024] Trial Registered Prospectively
Last Modified On: 12/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Importanat risk factor associated with heart failure and its effect on liver function  
Scientific Title of Study   Study of the Clinical Profile and Liver Function Abnormalities in Heart Failure  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Keyancy Patel 
Designation  Junior Resident 
Affiliation  D Y Patil medical college  
Address  Department of General Medicine Dr D Y Patil Medical College,Navi Mumbai Thane, MAHARASHTRA

Thane
MAHARASHTRA
400706
India 
Phone  9427131205  
Fax    
Email  patelkeyancy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Archana Bhate 
Designation  Head of Unit of Medicine  
Affiliation  D Y Patil medical college  
Address  Department of General Medicine Dr D Y Patil Medical College, Navi Mumbai, Thane, MAHARASHTRA

Thane
MAHARASHTRA
400706
India 
Phone  7021546998  
Fax    
Email  archbhate@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Keyancy Patel 
Designation  Junior Resident 
Affiliation  D Y Patil medical college  
Address  Department of General Medicine Dr D Y Patil Medical College,Navi Mumbai, Thane, MAHARASHTRA

Thane
MAHARASHTRA
400706
India 
Phone  9427131205  
Fax    
Email  patelkeyancy@gmail.com  
 
Source of Monetary or Material Support  
D Y Patil Hospital and School Of Medicine,Navi Mumbai 
 
Primary Sponsor  
Name  D Y Patil Hospital and School Of Medicine 
Address  D Y Patil Hospital ,Sector 5, near Ayyappa Temple, Nerul, Navi mumbai,400706 
Type of Sponsor  Private medical college 
 
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 Keyancy Patel  D Y Patil Hospital   D Y Patil Hospital- Medicine Department,3rd Floor hospital building ,Nerul,Thane Thane MAHARASHTRA
Thane
MAHARASHTRA 
9427131205

patelkeyancy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(ITC) for Biomedical Health and Research, Dr. D Y Patil Medical College, Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I509||Heart failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Patients with heart failure
2.Above age of 18 years 
 
ExclusionCriteria 
Details  1.History of alcoholism.
2.Past history of jaundice.
3.Recent intake of hepatotoxic and cholestatic drugs.
4.Hepatitis
5.Pregnancy.
6.Blood transfusion.
7.Hemolytic disorders.
8.Chronic liver disease 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)To analyze the clinical profile in patients with heart failure
2)To assess the liver function abnormalities in patients with heart failure 
Baseline
1 year  
 
Secondary Outcome  
Outcome  TimePoints 
To correlate the changes in liver function abnormalities in relation with the duration of
heart failure. 
Baseline
1 year 
 
Target Sample Size   Total Sample Size="230"
Sample Size from India="230" 
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)   31/12/2024 
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="1"
Months="0"
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   Heart failure (HF) is characterized by the inability of systemic perfusion to meet the body’s
metabolic demands and is usually caused by cardiac pump dysfunction and may
occasionally present with symptoms of a non cardiac disorder such as hepatic
dysfunction. A spectrum of hepatic derangement occur in HF particularly in the setting of
right heart failure (RHF). Passive hepatic congestion due to increased central venous
pressure may cause elevations of liver enzymes and both direct and indirect serum
bilirubin.Heart failure can severely decrease the functional capacity of a patient and
increase mortality risk. It is imperative to diagnose and effectively treat the disease to
prevent recurrent hospitalizations, improve quality of life, and enhance patient outcomes.
Present study was undertaken, mainly to emphasize the importance of early identification
of liver serum biochemical markers in heart failure patients. Early and adequate treatment
of the underlying cause of heart failure reverts liver function derangement to normal and
prevents permanent liver damage.
 
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