| CTRI Number |
CTRI/2024/02/062712 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
02/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on clinical profile of Increased pulmonary artery pressures in paediatric population |
|
Scientific Title of Study
|
Relationship between echocardiographic parameters and short-term prognosis of pulmonary hypertension among paediatric population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thashwini B P |
| Designation |
Postgraduate student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room No 212 2nd floor Department of Cardiovascular technology MCHP MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9353462843 |
| Fax |
|
| Email |
thashwinithash86824@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Jyothi |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room No 212 2nd floor Department of Cardiovascular technology MCHP MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9964586823 |
| Fax |
|
| Email |
samanth.jyothi@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Thashwini B P |
| Designation |
Postgraduate student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room No 212 2nd floor Department of Cardiovascular technology MCHP MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9353462843 |
| Fax |
|
| Email |
thashwinithash86824@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics
Kasturba Medical College
Manipal Academy of Higher Education Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal Academy of Higher Education Manipal |
| Address |
Kasturba Medical College and Hospital Tiger Circle Road Madhava Nagar Manipal Udupi Karnataka PIN- 576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Thashwini B P |
Kasturba Hospital Manipal |
Department of Paediatrics Kasturba Medical College Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA |
9353462843
thashwinithash86824@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I26-I28||Pulmonary heart disease and diseases of pulmonary circulation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All subjects having Pulmonary hypertension between the age group of 3 months and 18 years of age |
|
| ExclusionCriteria |
| Details |
Hemodynamically unstable paediatric population |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Right ventricular strain
Right ventricular systolic pressure |
At the recruitment
At three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Tricuspid annular plane systolic excursion
Right ventricular systolic tissue annular velocity
Right atrial area and volume
Left atrial area and volume
Tricuspid annulus dimension
Mitral annulus dimension |
At the recruitment
At three months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="23" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2024 |
| Date of Study Completion (India) |
31/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The study will be conducted after obtaining IRC and IEC approval and CTRI registration. After IRC and IEC approval and CTRI registration children who are diagnosed to have PH and who are referred for bedside echocardiography will be recruited in the study. Test details will be explained to the parents and participants. Informed consent will be taken from the parents as well as participants who are 12 years and above. The participant will undergo routine heart scan as directed by the physician as per standard guidelines. ECG gated standard views will be acquired using transthoracic echocardiography. Using 2D echocardiography, all the basic parameters including tissue Doppler velocity at septal and RV free wall are obtained. Conventional parameters like RA volume, RA area, LA volume, LA area and RV strain will also be obtained. Analysis of RV strain will be done offline using a presently marked semi-automated software Echo PAC version 202. All the procedures are done as a part of standard care, only the test results will be obtained from the patient files. No additional test or drug will be given to the participant for the purpose of this study.
|