| CTRI Number |
CTRI/2026/02/104302 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Can Magnesium Sulphate Help Treat Valvular Atrial Fibrillation? |
|
Scientific Title of Study
|
Role of Magnesium Sulphate as an adjunct to standard practice in patients with Valvular Atrial Fibrillation: A Randomized Controlled 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 |
Siddharth Sai Gunti Mohan |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Emergency Medicine, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
7065792610 |
| Fax |
|
| Email |
siddharthsai2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Yadav |
| Designation |
Head of the department |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Emergency Medicine, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9868026888 |
| Fax |
|
| Email |
rakeshyadav123@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Siddharth Sai Gunti Mohan |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Emergency Medicine, All India Institute of Medical Sciences, New Delhi
DELHI
110029
India |
| Phone |
7065792610 |
| Fax |
|
| Email |
siddharthsai2020@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Emergency Medicine, AIIMS New Delhi |
|
|
Primary Sponsor
|
| Name |
Department of Emergency Medicine, AIIMS 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 |
| Siddharth Sai Gunti Mohan |
All India Institue of medical sciences, New Delhi |
Depatment of Emergency Medicine, AIIMS New Delhi, 110029
New Delhi
DELHI |
7065792610
siddharthsai2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research ,AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I48||Atrial fibrillation and flutter, (2) ICD-10 Condition: I35||Nonrheumatic aortic valve disorders, (3) ICD-10 Condition: I34||Nonrheumatic mitral valve disorders, (4) ICD-10 Condition: Z952||Presence of prosthetic heart valve, (5) ICD-10 Condition: I080||Rheumatic disorders of both mitraland aortic valves, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Magnesium sulphate along with standard practice |
2 grams MgSO4 in 100 ml normal saline administered over 10 min.
this is given as an adjunct to the standard of practice (SOP) for treating atrial fibrillation.
SOP - determined by treating physician |
| Comparator Agent |
standard of practice |
Standard of practice (SOP) for atrial fibrillation as decided by the treating physician |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting to the emergency department with valvular atrial fibrillation with fast ventricular rate
Age greater than or equal to 18 years
Patients / Legally authorised representative willing to give valid consent
|
|
| ExclusionCriteria |
| Details |
1.Age below 18 years
2.Systolic blood pressure less than 90 mmHg
3.Atrial fibrillation associated with Wolff-Parkinson-White syndrome
4.Known chronic kidney disease with creatinine clearance below 30 ml/min
5.Presence of acute coronary syndrome
6.Pregnancy
7.Lack of consent from the patient
8.History of chronic malignancy
9.Known allergy to magnesium |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the proportion of successful rate control by intravenous magnesium sulphate along with standard practice as compared to standard practice alone in patients of valvular atrial fibrillation |
baseline and 12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine the proportion of successful rhythm control by intravenous magnesium sulphate along with standard practice as compared to standard practice alone in patients of valvular atrial fibrillation.
2. To determine the cumulative doses of AV nodal blocking agents required for rate control measure in patients with valvular atrial fibrillation receiving intravenous magnesium sulphate along with standard practice as compared to standard practice alone, until hospital discharge.
3. To determine the length of hospital stay in patients with valvular atrial fibrillation receiving intravenous magnesium sulphate along with standard practice as compared to standard practice alone.
4. To determine the safety outcomes of using intravenous magnesium sulphate in patients of valvular atrial fibrillation in terms of hypotension, use of vasopressors, patient reported flushing, non-invasive or mechanical ventilation & all-cause mortality until hospital discharge |
baseline 12 hours 28 days |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
01/03/2026 |
| 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="6"
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
|
Atrial fibrillation presents differently across populations In Western countries it predominantly affects older adults due to age related atrial fibrosis hypertrophy and increased calcium transients in cardiomyocytes In India however rheumatic heart disease remains the primary cause especially in younger patients RHD leads to mitral valve stenosis causing left atrial dilation fibrosis and electrical remodeling key contributors to AF This regional variation underscores the need for targeted treatment strategies Magnesium sulphate a calcium antagonist reduces myocardial excitability by limiting calcium influx making it effective for rate control in AF Studies have shown that low dose intravenous Magnesium sulphate less than 5g significantly improves heart rate control when used with standard therapy particularly in atrial fibrillation with rapid ventricular response Meta analyses and clinical trials indicate that Magnesium sulphate enhances rate reduction maintains lower heart rates longercand may accelerate therapeutic response Given the prevalence of valvular AF in India particularly from RHD this study explores the potential of Magnesium sulphate as an adjunct therapy to improve outcomes in this high risk group |