Comparing Two Heart Medicines for Fast, Irregular Heartbeat (Atrial Fibrillation)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMuhammad Ali Javed
About this trial
The goal of this clinical trial is to learn whether intravenous verapamil or intravenous metoprolol controls heart rate more effectively in adult patients who arrive at the emergency department with atrial fibrillation and a fast heart rate (rapid ventricular response), but who are otherwise medically stable. Atrial fibrillation with a rapid heart rate is a common emergency, and doctors currently choose between these two standard medicines based on personal preference rather than strong local evidence, since there is limited research on this comparison in Pakistani patients.
The main questions this study aims to answer are:
Does a higher proportion of patients reach a target heart rate of less than 110 beats per minute within 30 minutes with verapamil compared to metoprolol? Which medicine controls the heart rate faster, on average? Are there differences in side effects (such as low blood pressure, slow heart rate, or breathing problems) between the two medicines? Researchers will compare a group of patients receiving verapamil to a group receiving metoprolol to see if one medicine controls the heart rate faster and more safely than the other.
Participants will:
1. Receive either verapamil or metoprolol through an IV, with the dose given according to standard protocols 2. Have their heart rate, blood pressure, and oxygen levels monitored continuously for 30 minutes after the medicine is given 3. Be observed for any side effects during this monitoring period Both medicines used in this study are already standard, guideline-recommended treatments for this condition, so participation will not change or delay the medical care patients would normally receive.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged 18 years and above presenting to the Emergency Department
Confirmed diagnosis of atrial fibrillation with rapid ventricular response (heart rate ≥110 bpm) on 12-lead ECG
Hemodynamically stable at the time of enrollment (systolic blood pressure ≥90 mmHg, no shock, no acute pulmonary edema)
Willingness to provide written informed consent
Disqualifiers
Hemodynamic instability, cardiogenic shock, or acute decompensated heart failure
Known pre-excitation syndrome (e.g., Wolff-Parkinson-White syndrome) on baseline ECG
Severe left ventricular systolic dysfunction (ejection fraction less than 30%) as determined by echocardiography
Known hypersensitivity or contraindication to verapamil or metoprolol
Trial design
Design model
Parallel
Treatments tested in this trial
Verapamil Hydrochloride
DrugIntravenous verapamil administered as an initial 5 mg dose over 2 minutes, with an additional 5 mg dose permitted after 15 minutes if target heart rate not achieved, up to a cumulative maximum of 10 mg.
Metoprolol tartrate
DrugIntravenous metoprolol tartrate administered as an initial 5 mg dose over 2 minutes, with up to two additional 5 mg doses at 5-minute intervals if target heart rate not achieved, up to a cumulative maximum of 15 mg.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Verapamil groupActive comparator 1 intervention
Group B: Metoprolol groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of Participants Achieving Target Heart Rate Control Within 30 Minutes
Percentage of participants in each treatment group achieving a ventricular rate of less than 110 beats per minute, as measured by continuous cardiac monitoring, within 30 minutes of study drug administration.
Time frame
30 minutes after study drug administrationSecondary outcomes
1
Time to Achievement of Target Heart Rate
Time in minutes from the start of study drug administration until the first recorded heart rate below 110 beats per minute on continuous cardiac monitoring.
Time frame
Measured continuously from time 0 up to 30 minutes post-drug administration2
Number of Participants with Adverse Drug Events
Number of participants experiencing a clinically significant adverse drug event, defined as symptomatic hypotension (systolic blood pressure \<90 mmHg), bradycardia (heart rate \<50 bpm), high-degree atrioventricular block (second or third degree), bronchospasm, or any event necessitating discontinuation of the study drug.
Time frame
From study drug administration up to 30 minutesLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Muhammad Ali Javed
Lead sponsor
Wah Medical college , POF hospital
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: