| CTRI Number |
CTRI/2018/08/015182 [Registered on: 03/08/2018] Trial Registered Prospectively |
| Last Modified On: |
23/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two drugs, ivabradine and amiodarone, in the management of Junctional ectopic tachycardia , an abnormality in cardiac rhythm in patients under 18 years who undergo cardiac surgery |
|
Scientific Title of Study
|
Randomized trial on Efficacy of Ivabradine, compared with amiodarone, in conversion of Junctional ectopic tachycardia to sinus rhythm in post operative cardiac surgical patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arvind B |
| Designation |
Senior Resident |
| Affiliation |
Department of Cardiology, AIIMS, New Delhi |
| Address |
Department of Cardiology,
Cardiothoracic Sciences center
AIIMS
New Delhi
South
DELHI
110029
India |
| Phone |
8527619871 |
| Fax |
|
| Email |
drbarvind@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SS Kothari |
| Designation |
Professor |
| Affiliation |
Department of Cardiology, AIIMS, New Delhi |
| Address |
Department of Cardiology,
Cardiothoracic Sciences center
AIIMS
New Delhi
South
DELHI
110029
India |
| Phone |
9868398166 |
| Fax |
|
| Email |
kothariss100@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arvind B |
| Designation |
Senior Resident |
| Affiliation |
Department of Cardiology, AIIMS, New Delhi |
| Address |
Department of Cardiology,
Cardiothoracic Sciences center
AIIMS
New Delhi
South
DELHI
110029
India |
| Phone |
8527619871 |
| Fax |
|
| Email |
drbarvind@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
All India Institute of Medical Sciences
New Delhi |
| 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 |
| Arvind B |
Department of Cardiology and cardiac surgical Intensive Care Unit |
Cardiothoracic Sciences Center
South
DELHI |
8527619871
drbarvind@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for postgraduate research, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I499||Cardiac arrhythmia, unspecified, Post cardiac surgery patients with Junctional Ectopic Tachycardia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Amiodarone |
Drug which has been used in the management of JET , with variable degrees of success |
| Intervention |
Ivabradine |
A oral drug used in management of Heart failure and sinus tachycardia |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1.Pediatric Patients who undergo corrective Open Heart surgery for various congenital heart diseases electively (Age < 18 years)
2.Patients who develop JET until 1 month of surgery
3. Parents/ Guardians of the children giving written informed consent
|
|
| ExclusionCriteria |
| Details |
1 Patients who have Preoperative arrhythmias or who are already on Anti- arrhythmics
2 Preoperative hospital stay > 7 days
3 Severe Liver Dysfunction
4 Multi Organ Dysfunction
5 Parents/ Guardians not giving written consent for inclusion in the trial
6 All emergency surgeries
7 All closed heart surgeries
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Restoration of normal sinus rhythm
|
Upto 48 hour after institution of therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcomes:
1. Controlling of heart rate to age acceptable levels (140 bpm (in upto 3 months),120 bpm in 3months – 2 years and 100 bpm in older children) that allows hemodynamic improvement with/without atrial or AV sequential pacing
2. Time taken to achieve NSR/ Rate control
|
Upto 48 hour after institution of therapy |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
06/08/2018 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Junctional Ectopic Tachycardia (JET) in
postoperative period is a serious arrhythmia, which often leads to hemodynamic
instability, decreased cardiac output, resulting in serious morbidity and
mortality. Hence it is important in achieving rapid control of JET. None of the drugs have been shown to be
consistently effective in controlling this arrhythmia. Amiodarone has fared
well in this respect, over other drugs, but adverse effects have been commonly
reported with its usage. Recently there are case reports stating that
Ivabradine is safe and effective in both congenital and postoperative JET, with
a better dosing and adverse effect profile. There has not been any prospective
study to demonstrate the same. So we planned this prospective Randomised control trial comparing the efficacy of both these drugs in the management of postoperative JET |