| CTRI Number |
CTRI/2023/03/050230 [Registered on: 02/03/2023] Trial Registered Prospectively |
| Last Modified On: |
01/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
This study is designed to know the characterestics of heart failure and to determine role of AST/ALT ratio in the severity of heart failure |
|
Scientific Title of Study
|
Clinical profile of heart failure and AST/ALT ratio as a marker of severity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Varun Anil Parmar |
| Designation |
Junior resident |
| Affiliation |
Department of General Medicine, Kasturba Medical College, Manipal |
| Address |
Department of General medicine, OPD building, Kasturba Hospital,Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
parmar.anil@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRaviraj Acharya |
| Designation |
Professor |
| Affiliation |
Department of General Medicine, Kasturba Medical College, Manipal |
| Address |
Department of General medicine, OPD building, Kasturba Hospital,Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
rvacharya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Varun Anil Parmar |
| Designation |
Junior resident |
| Affiliation |
Department of General Medicine, Kasturba Medical College, Manipal |
| Address |
Department of General medicine, OPD building, Kasturba Hospital,Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
parmar.anil@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Varun Anil Parmar |
| Address |
Department of medicine, OPD building, Kasturba hospital, Madhav Nagar, Manipal, Karnataka, 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 |
| Varun Parmar |
Kasturba Hospital, Manipal |
Department of General Medicine, Room number 206, OPD Block, KMCH, Manipal
Udupi
KARNATAKA |
9769484625
parmar.anil@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee -2, Kasturba medical college and Kasturba hospital |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Heart failure with reduced ejection fraction
2. Heart failure with preserved ejection fraction
|
|
| ExclusionCriteria |
| Details |
1. Primary liver disease
2. Renal failure
3. Sepsis
4. Shock
5. Pregnancy
6. Malignancy
7. Muscle injury
8. Recent surgery
9. History of significant alcohol usage
10. Hepatotoxic drugs
11. Evidence of statin induced liver injury |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| AST/ALT ratio relation to severity of Heart Failure |
Cross sectional study involving each patient at presentation
Data will be compiled at end of study i.e. 22 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical Profile of Heart Failure |
Data to be compiled at end of study |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
11/03/2023 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Heart failure is a commonly encountered syndrome in clinical practice. It is important to identify and lay out the clinical profile of the same-to assist in the timely detection and treatment of the same and recognition of risk factors for same. There is also an ever-present need to identify relatively inexpensive biomarkers and investigation of AST/ALT ratio for same is a promising approach. This research project aims to address these issues. After CTRI registration, participant selection will be carried out as per criteria-consent shall be taken and following which they will be subjected to questionnaire based on which data sets will be compiled and analysed |