| CTRI Number |
CTRI/2025/04/084689 [Registered on: 13/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To explain about heart right sided function by echo scan in dilated heart patients |
|
Scientific Title of Study
|
Screening of Right Ventricular Function by Echocardiography in Patient with dilated Cardiomyopathy
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GREESHMA G S |
| Designation |
Postgraduate student |
| Affiliation |
Manipal Academy Of Higher Education |
| Address |
Manipal hospitals,Department of Cardiology,Echo Room
#98 HAL Old airport road ,Kodihalli,Bengaluru , 560017
Bangalore
KARNATAKA
560017
India |
| Phone |
8296637939 |
| Fax |
|
| Email |
ganigagreeshmags@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rekha V |
| Designation |
Assistant professor selection grade |
| Affiliation |
Manipal Academy Of Higher Education |
| Address |
Manipal hospitals,Department of Cardiology,Echo Room
#98 HAL Old airport road ,Kodihalli,Bengaluru , 560017
Bangalore
KARNATAKA
560017
India |
| Phone |
9663682484 |
| Fax |
|
| Email |
rekha.v@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Rekha V |
| Designation |
Assistant professor selection grade |
| Affiliation |
Manipal Academy Of Higher Education |
| Address |
Manipal hospitals,Department of Cardiology,Echo Room
#98 HAL Old airport road ,Kodihalli,Bengaluru , 560017
Bangalore
KARNATAKA
560017
India |
| Phone |
9663682484 |
| Fax |
|
| Email |
rekha.v@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Hospital #98 HAL Old airport road Kodihalli, Bangalore 560017, India |
|
|
Primary Sponsor
|
| Name |
N/A |
| Address |
N/A |
| Type of Sponsor |
Other [SELF SPONSER] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SELF SPONSOR |
MANIPAL HOSPITALS, 98 HAL OLD AIRPORT ROAD KODIHALLI BENGALURU 560017 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rekha V |
Manipal hospital |
Department of Cardiology ,Echo Room
#98, HAL Old aiport road ,Kodihalli,Bangalore,560017
Bangalore
KARNATAKA |
9663682484
rekha.v@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE OF MANIPAL HOSPITALS BANGALORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I420||Dilated cardiomyopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with dilated cardiomyopathy with more than 18 years of age |
|
| ExclusionCriteria |
| Details |
1. Patient with rheumatic heart disease
2. COPD Patients
3 Patients with ECG rhythm showing other than sinus rhythm, complete RBBB or LBBB,pacemaker or defibrillators |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To screen the RV function by echocardiography in patients with dilated cardiomyopathy |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To review the alteration of RV dimensions & function associated in patients with dilated cardiomyopathy |
6 Months |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
01/05/2025 |
| 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="0"
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
|
DILATED CARDIOMYOPATHY IS MYOCARDIAL DISEASE CHARACTERISED BY IMPAIRED LV SYSTOLIC FUNCTION IN CONJUNCTION WITH ENLARGEMENT OF CARDIAC CHAMBER , CAUSED BY FAMILIAL , GENETIC , VIRAL , IMMUNE , ALCOHOLIC OR UNKNOWN FACTORS . DILATED CARDIOMYOPATHY IS THE SECOND MOST COMMON CAUISES OF HEART FAILURE.
TO REVIEW THE ALTERATION OF RV DIMENSIONS AND FUNCTIONS ASSOCIATED WITH PATIENTS WITH DILATED CARDIOMYOPATHY
RV FUNCTION CAN BE ASSESSED BY RV DIMENSIONS , TAPSE ( TRICUSPID ANNULAR PLANE SYSTOLIC EXCURSION ) , PASP MEASUREMENT , RV TDI S’ , RV GLOBAL STRAIN , RV MPI ( MYOCARDIAL PERFORMANCE INDEX ) , RV FAC ( FRACTIONAL AREA CHANGE ) .
|