| CTRI Number |
CTRI/2023/08/056785 [Registered on: 23/08/2023] Trial Registered Prospectively |
| Last Modified On: |
21/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To establish the correlation between level of serum NT PRO BNP and the severity of congenital heart disease in children |
|
Scientific Title of Study
|
To establish the correlation between the level of serum NT-PRO Brain Natriuretic Peptide and severity of left to right shunt (Qp/Qs) ratio in children with Acyanotic congenital heart disease -A cross sectional 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 Ankit Anand |
| Designation |
PG MD Paediatrics |
| Affiliation |
Jawaharlal Nehru medical College |
| Address |
Department of Paediatrics
Jawaharlal Nehru medical College
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8210983703 |
| Fax |
|
| Email |
ankitanand120@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veeresh Manvi |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru medical College |
| Address |
Department of Paediatrics
Jawaharlal Nehru medical College
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9164000009 |
| Fax |
|
| Email |
manviveeresh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankit Anand |
| Designation |
PG MD Paediatrics |
| Affiliation |
Jawaharlal Nehru medical College |
| Address |
Department of Paediatrics
Jawaharlal Nehru medical College
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8210983703 |
| Fax |
|
| Email |
ankitanand120@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal nehru Medical college Belagavi |
|
|
Primary Sponsor
|
| Name |
Jawaharlal nehru medical college |
| Address |
Department of Paediatrics
Jawaharlal Nehru medical College
Belagavi |
| Type of Sponsor |
Private medical college |
|
|
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 Ankit Anand |
Dr KLE Prabhakar kore hospital and research centre |
Department of Paediatric
Jawaharlal nehru medical college
Belagavi
Belgaum
KARNATAKA |
8210983703
ankitanand120@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I998||Other disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
All infant and children presenting with heart murmur, features of CCF, failure to thrive or history of recurrent respiratory infection, diagnosed to have ASD, VSD, PDA under echocardiography. |
|
| ExclusionCriteria |
| Details |
Children with: 1. Septic shock, Thrombocytopenia 2. Renal failure, Low GFR
3. Active NEC, Active bleeding, Intra cranial Hemorrhage
4. Heart failure due to cardiomyopathy, myocarditis, pericarditis or coronary artery
disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To establish a relation between serum NT pro BNP levels & severity of shunt in patients of left to right shunt ASD VSD and PDA & other acyanotic conditions based on echocardiographic and hemodynamic evaluations |
1 year hospital based study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine cutoff point for surgical intervention in such patients |
1 year hospital based study |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/09/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The Natriuretic peptides including BNP, ANP and pro BNP are secreted primarily by atrial and ventricular cardiomyocytes stretching, it has vasodilatory, natriuretic actions along with inhibition of RAAS and cardiac sympathetic activity. They are established most powerful markers for heart failure diagnosis and prognosis in across a spectrum of cardiovascular diseases.
The aim is to establish a reference range of NT-proBNP with the severity of shunt in Acyanotic congenital heart diseases. No Indian reference ranges/ cut off points have been established yet for the classification of severity of shunt (mild, moderate, severe) in CHDs. And since the quantity of shunt is not always perfectly determined by echocardiography and there is immense shortage of cardiologists in country especially Rural areas, we aimed at evaluating whether the serum level of BNP can be used as a screening marker for determining the amount and severity of left to right shunt in patients of VSD, ASD, PDA and other acyanotic conditions thus establish a cut off point for surgical intervention as well.
It would also serve as a good way to triage the patients for Echo cardiography, Determining the severity of the shunt can help prevent morbidities in patients of Congestive heart failure, Failure to thrive and Eisenmenger syndromes. |