| CTRI Number |
CTRI/2025/04/085450 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To Study The Presenting Symptoms And Imaging Features In Patients With Hypertrophic Cardiomyopathy |
|
Scientific Title of Study
|
To Study The Clinical Profile And Imaging Features In Patients With Hypertrophic Cardiomyopathy-A Pilot Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saroj Kumar Sahoo |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Cardiology Department
AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9914663618 |
| Fax |
|
| Email |
saroj.sahoo8405@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabhat Kumar Singh |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Cardiology Department
AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9672785845 |
| Fax |
|
| Email |
prabhat96727@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saroj Kumar Sahoo |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Cardiology Department
AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9914663618 |
| Fax |
|
| Email |
saroj.sahoo8405@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar
State-Odisha
India
Pin code-751019 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Prabhat Kumar Singh |
AIIMS Bhubaneswar |
Second Floor OPD building, Room Number 259, Cardiology Department,
Khordha
ORISSA |
9672785845
prabhat96727@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR FACULTY RESEARCH AIIMS BHUBANESWAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I422||Other hypertrophic cardiomyopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
HCM patient as defined by ACC of age more than 14 years |
|
| ExclusionCriteria |
| Details |
Patient who have any history or diagnosis which can lead to LVH
1.Hypertension, Aortic stenosis, Chronic kidney Disease e.t.c |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Objective – To study the clinical profile and
imaging features in patients with hypertrophic
cardiomyopathy
|
At the time of admission and after seven days of admission-analysis of all investigations will be done |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation between
Electrophysiological study(EPS), External loop
recorder(ELR) findings & Cardiac MRI findings of
hypertrophic cardiomyopathy patients |
At the time of admission & after seven days of admission-analysis of all investigations will be done |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
08/05/2025 |
| 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="6"
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
|
HCM is most common autosomal dominant cardiomyopathy. Although palpitation is one of the common presentation of HCM, it can also present as sudden cardiac death. Relation of Clinical symptoms, ELR, EPS, CAG and its imaging correlation has not been explored deeply. Moreover detail data regarding epidemiology and clinical profile of HCM patients in East India is lacking. This study has been designed to fill this lacunae. |