| CTRI Number |
CTRI/2024/07/070332 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Early ACE inhibitor use in children with medium sized ventricular septal defects with congestive heart failure: A single-center randomized trial |
|
Scientific Title of Study
|
Assessment of efficacy of early introduction of ACE (angiotensin converting enzyme) inhibitors in treatment of congestive heart failure in children with medium sized ventricular septal defects: a single center open label randomized trial |
| 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 Chandra Raj Datta |
| Designation |
Junior resident (academic) |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
Department of
Pediatrics, 2nd floor, IPD Building, AIIMS Patna
Patna
BIHAR
801507
India |
| Phone |
7031303412 |
| Fax |
|
| Email |
chandrarajdatta15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Prasad |
| Designation |
Professor, Department of Pediatrics, AIIMS Patna |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
Department of
Pediatrics, 2nd floor, IPD Building, AIIMS Patna.
Patna
BIHAR
801507
India |
| Phone |
9472140820 |
| Fax |
|
| Email |
drarunp@aiimspatna.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandra Raj Datta |
| Designation |
Junior resident (academic) |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
Department of
Pediatrics, 2nd floor, IPD Building, AIIMS Patna
Patna
BIHAR
801507
India |
| Phone |
7031303412 |
| Fax |
|
| Email |
chandrarajdatta15@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Patna |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Patna |
| Address |
Phulwarisharif, Patna, Bihar-801507, India |
| Type of Sponsor |
Government 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 Chandra Raj Datta |
All India Institute of Medical Sciences, Patna |
Department of
Pediatrics, 2nd floor, IPD Building, AIIMS Patna
Patna
BIHAR |
7031303412
chandrarajdatta15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee, All India Institute of Medical Sciences, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I509||Heart failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Early introduction of ACE (angiotensin converting enzyme) inhibitor - enalapril |
Furosemide at dose of 2 mg/kg/day q12hr through oral route ; Enalapril at dose of 0.1 mg/kg/day q24hr through oral route started within 24 hours of starting furosemide
The drug Enalapril and Furosemide which will be used in intervention group are established and widely used treatment for VSD with congestive heart failure, they will be used till resolution of symptoms. |
| Comparator Agent |
Treatment with furosemide |
Furosemide at dose of 2 mg/kg/day q12hr through oral route
The drug Furosemide which will be used in control group is an established and widely used treatment for VSD with congestive heart failure, it will be used till resolution of symptoms. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
All children aged 1 month to 10 years of either sex with medium sized VSD (diagnosed by 2D echo) presenting with congestive heart failure |
|
| ExclusionCriteria |
| Details |
i. Patients already on enalapril
ii. Patients who have already undergone surgical correction of VSD
iii. Patients with small and large sized VSD
iv. Patients with renal dysfunction or hyperkalemia
v. Patients with cardiogenic shock |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Resolution of respiratory distress (based on respiratory rate (/min) (resolution of tachypnea), retractions – subcostal/intercostal/suprasternal, nasal flaring and grunting). |
1 week and 1 month after starting intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i. Resolution of signs of heart failure – regression of liver size below right costal margin (in cm) and difference in liver span (in cm)
ii. Number of admissions and total days of admission
iii. Recurrence of respiratory distress – tachypnea or retractions (assess at 1 week and 1 month) |
1 week and 1 month after starting intervention |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
22/07/2024 |
| 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
|
Aim of the study: To assess the efficacy of early introduction of ACE
(angiotensin converting enzyme) inhibitors in treatment of congestive heart
failure in children with medium sized ventricular septal defects. Primary Objective: To assess the efficacy of early introduction of ACE
(angiotensin converting enzyme) inhibitors in treatment of congestive heart
failure in children with medium sized ventricular septal defects. The efficacy
will be assessed based on resolution of respiratory distress (respiratory rate
(resolution of tachypnea), retractions – subcostal/intercostal/suprasternal,
nasal flaring and grunting) and resolution of signs of heart failure –
regression of liver size below right costal margin. Secondary Objectives: i. To observe and analyze the spectrum
of patients presenting with VSD in AIIMS Patna.
ii. To
assess the duration of treatment with diuretics and enalapril after
which clinical symptoms of congestive heart failure improve in patients with moderate VSD.
Hypothesis: a. Null hypothesis (H0): There is no difference in resolution of symptoms and
signs of congestive heart failure with early introduction of ACE inhibitors in
patients with medium sized VSD.
b. Alternate hypothesis (H1): There
is better resolution of symptoms and signs of congestive heart failure with early
introduction of ACE inhibitors in children with medium sized VSD. |