| CTRI Number |
CTRI/2025/04/084362 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Hypertrophic cardiomyopathy means abnormal thickening of the heart muscle .Its very important to assess Right heart muscle function for better prognosis .In which we do heart scan and assess regional and global parameters evaluation of right ventricle . |
|
Scientific Title of Study
|
Assessment of right ventricular function by echocardiography in patients with hypertrophic 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 |
ROSHNI CAROL GONSALVES |
| Designation |
post graduate 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 |
8867225499 |
| Fax |
|
| Email |
roshnigonsalves120@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rekha V |
| Designation |
Assistant professor selection grade |
| Affiliation |
Manipal academy of higher education |
| Address |
MANIPAL HOSPITAL DEPARTMENT OF CARDIOLOGY #98, HAL old airport road , Kodihalli , Bengaluru
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 HOSPITAL DEPARTMENT OF CARDIOLOGY #98, HAL old airport road , Kodihalli , Bengaluru
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 BENGALURU 560017 INDIA |
|
|
Primary Sponsor
|
| Name |
ROSHNI CAROL GONSALVES |
| Address |
#98 HAL OLD AIRPORT ROAD KODIHALLI BENGALURU 560017 |
| Type of Sponsor |
Other [self sponsor] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| self sponsor |
# 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 airport road , Kodihalli , Bengaluru , 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: I422||Other hypertrophic cardiomyopathy, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Hypertrophic cardiomyopathy patients with obstructive or non obstructive types |
|
| ExclusionCriteria |
| Details |
1.Post septal myectomy patients
2.valvular heart diseases
3.pericardial diseases
4.Hypertensive heart disease more than 2 medications
5.other cardiomyopthy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the right ventricular function by echocardiography in patients with hypertrophic cardiomyopathy . This study will indicate whether Right ventricular function is good or bad |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess RV function by 2D echocardiography , M-mode and speckle tracking in hypertrophic cardiomyopathy patients |
6 months |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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
|
Hypertrophic cardiomyopathy is a condition where the heart muscle becomes abnormally thick , most commonly affecting the wall between the two ventricles .This thickening can make it harder for the heart to pump blood effectively . RV systolic function can be assessed using regional measurements like tricuspid annular plane systolic excursion (TAPSE), maximal systolic velocity in the tricuspid annulus (TDI RV S’) , or global measurement with RV fractional area change (FAC), RV global strain and RV index myocardial performance (MPI).
To assess the right ventricular dimensions and function associated with Hypertrophic cardiomyopathy To assess the right ventricular dysfunction in patients with Hypertrophic cardiomyopathy based on echocardiographic parameters |