| CTRI Number |
CTRI/2024/10/075156 [Registered on: 11/10/2024] Trial Registered Prospectively |
| Last Modified On: |
09/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two class of drugs in controlling fast heart rate in arrhythmia |
|
Scientific Title of Study
|
Beta blockers vs Calcium channel blockers for rate control in Atrial Fibrillation with fast ventricular rate:A randomised open labelled 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 Anil Akhil |
| Designation |
Junior resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Emergency Medicine,AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8790186655 |
| Fax |
|
| Email |
anilakhil4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakash Ranjan Mishra |
| Designation |
Associate Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Emergency Medicine,AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8826118924 |
| Fax |
|
| Email |
ranjan.prakashmishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Akhil |
| Designation |
Junior resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Emergency Medicine,AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8790186655 |
| Fax |
|
| Email |
anilakhil4@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,New Delhi,Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
Department of Emergency MedicineAIIMS New Delhi |
| Address |
AIIMS,New Delhi,Delhi 110029 |
| 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 |
| DrAnil Akhil |
AIl India Institute of Medical Sciences, New Delhi |
Department of Emergency Medicine,Ansari Nagar,AIIMS New Delhi 110029
New Delhi
DELHI |
8790186655
anilakhil4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for post graduate research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I489||Unspecified atrial fibrillation and atrial flutter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Betablocker(Metoprolol) |
Metoprolol 5mg intravenously 5 minutes apart for a total of 3 doses to see response in heart rate |
| Intervention |
Calcium channel blocker(Diltiazem) |
Diltiazem is given at 0.25mg/kg(max-20mg) intravenously followed by 0.35 mg/kg(max-30mg) after 15 mins to see response in heart rate |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All hemodynamically stable patients presenting to ED with ECG showing Atrial fibrillation with fast ventricular rate more than 110 beats per minute,consenting for study |
|
| ExclusionCriteria |
| Details |
1.pregnancy
2.systolic blood pressure less than 90mm of mercury
3.heart rate more than 220 beats per minute
4.QRS duration more than 120 milliseconds
5.Febrile patients with temperature more than 38 celsius
6.ECG suggestive of acute ST elevation Myocardial infarction
7.History of allergy to Diltiazem or Metoprolol
8.Acute decompensated heart failure patients with ejection fraction less than 40% or NYHA class 3,4 or patients with active wheezing or history of Bronchial asthma and Chronic obstructive pulmonary disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effects of Metoprolol versus Diltiazem in decreasing heart rate to less than 110 beats per minute or 20% reduction of initial heart rate within 30 minutes of drug intake |
The outcome of drug intake are estimated after 30 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the incidence of hypotension(systolic blood pressure to less than 90 mm of mercury) and bradycardia (heart rate less than 60 beats per minute) |
within 30 minutes of drug administration |
| To evaluate the incidence of requirement of second dose of same medication or subsequent doses of other class medication for rate control |
Within 30 minutes of drug administration |
| To evaluate the incidence of length of ED stay |
Within 30 minutes of drug administration |
|
|
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)
|
20/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
This is a prospective, open labelled, randomised control trial of parallel group to compare the effects of intravenous Metoprolol versus Diltiazem in controlling heart rate in hemodynamically stable patients presenting to Emergency department with ECG features suggestive of Atrial Fibrillatiion with fast ventricular rate.Patients more than or equal to 18 years with an ECG evidence of fibrillation with heart rate more than 110 are included in the study after excluding patients meeting excluding criteria.Then patient will be randomised in two different arm based on block randomisation using computer generated sequences and allocation concealment will be done. Primary objective is to compare the effects of Metoprolol v/s Diltiazem in decreasing heart rate to less than 110 bpm or 20% reduction of initial heart rate within 30 minutes of drug administration, secondary objectives would be to evaluate the incidence of hypotension, bradycardia and requirement of second dose of same medication or subsequent doses of other class of medications for rate control and length of hospital stay in such patients. |