| 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
|
|
|
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
|
|
|
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. |