Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06276127
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-02-18
Brief Title:
Oral Bisoprolol Vs IV Diltiazem in Atrial Fibrillation or Flutter With Rapid Ventricular Rate
Sponsor:
Oman Medical Speciality Board
Organization:
Oman Medical Speciality Board
Study Overview
Official Title:
Oral Bisoprolol Versus Intravenous Diltiazem in the Management of Atrial Fibrillation or Flutter With Rapid Ventricular Rate in the Emergency Department A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BisoAF
Brief Summary:
INTRODUCTION The study focuses on comparing the effectiveness of oral Bisoprolol a beta-1 adrenergic receptor blocker against intravenous Diltiazem a calcium channel blocker in treating rapid atrial fibrillation or flutter with rapid ventricular response in an emergency setting This research aims to fill the gap in empirical evidence regarding the use of oral Bisoprolol for these conditions potentially offering a convenient evidence-based alternative for patient management in emergency departments where established protocols are lacking
METHOD This study is a randomized controlled trial targeting patients who present to the emergency room with symptomatic atrial fibrillation or flutter and rapid ventricular response requiring intervention Participants will be split into two groups and undergo continuous monitoring of vital signs and regular electrocardiograms to ensure safety and document any adverse effects The primary focus is on patient safety while evaluating the efficacy of the treatments
AIM Evaluate the efficacy and safety of oral bisoprolol in treating atrial fibrillation or atrial flutter with rapid ventricular response in an emergency department setting
PRIMARY OJECTIVES The primary efficacy outcome will be evaluated by achieving a HR110 beats per minute or a decrease 20 of baseline HR at 60 minutes The primary safety outcome measures are HR 60 bpm and SBP 95 mm Hg
SECONDARY OBJECTIVES The use of Rescue medication proportion of patients who required hospitalization worsening of heart failure or pulmonary oedema side effect of medication dizziness headaches gastrointestinal symptoms
PATEINT POPULATION Adults 18 and older presenting to the emergency department at Sultan Qaboos University Hospital with symptomatic atrial fibrillation or atrial flutter with rapid ventricular response requiring treatment
INTERVENTION A single oral dose of 5 mg Bisoprolol maximum dose of 5 mg or a single intravenous dose of Diltiazem at 025 mgkg to a maximum dose of 30 mg
CLINICAL MEASURMENT Heart rate recorded every 15 minutes up to the 90-minute mark with a 12-lead ECG performed every 30 minutes
OUTCOME For therapy to be considered effective patients must achieve a ventricular rate 110min or experience a drop-in ventricular rate of at least 20 at 60 minutes
METHOD This study is a randomized controlled trial targeting patients who present to the emergency room with symptomatic atrial fibrillation or flutter and rapid ventricular response requiring intervention Participants will be split into two groups and undergo continuous monitoring of vital signs and regular electrocardiograms to ensure safety and document any adverse effects The primary focus is on patient safety while evaluating the efficacy of the treatments
AIM Evaluate the efficacy and safety of oral bisoprolol in treating atrial fibrillation or atrial flutter with rapid ventricular response in an emergency department setting
PRIMARY OJECTIVES The primary efficacy outcome will be evaluated by achieving a HR110 beats per minute or a decrease 20 of baseline HR at 60 minutes The primary safety outcome measures are HR 60 bpm and SBP 95 mm Hg
SECONDARY OBJECTIVES The use of Rescue medication proportion of patients who required hospitalization worsening of heart failure or pulmonary oedema side effect of medication dizziness headaches gastrointestinal symptoms
PATEINT POPULATION Adults 18 and older presenting to the emergency department at Sultan Qaboos University Hospital with symptomatic atrial fibrillation or atrial flutter with rapid ventricular response requiring treatment
INTERVENTION A single oral dose of 5 mg Bisoprolol maximum dose of 5 mg or a single intravenous dose of Diltiazem at 025 mgkg to a maximum dose of 30 mg
CLINICAL MEASURMENT Heart rate recorded every 15 minutes up to the 90-minute mark with a 12-lead ECG performed every 30 minutes
OUTCOME For therapy to be considered effective patients must achieve a ventricular rate 110min or experience a drop-in ventricular rate of at least 20 at 60 minutes
Detailed Description:
Aim of the Study This randomized controlled trial RCT aims to assess the effectiveness and safety of oral bisoprolol in treating atrial fibrillation AF with rapid ventricular response RVR and atrial flutter within an acute ED setting We aim to determine the viability of utilizing oral bisoprolol as a primary treatment option for atrial fibrillation with rapid ventricular response RVR and atrial flutter by evaluating its clinical outcomes focusing on rate control and potential adverse effects and comparing them with those of intravenous diltiazem The findings from this research will enhance our understanding and guide clinicians towards evidence-based therapeutic decisions ensuring optimal patient care and improved outcomes
Research Objectives and Hypothesis The research aims to test the null hypothesis which posits that there is no significant difference in achieving a heart rate HR below 110 beatsmin or a reduction in ventricular rate by at least 20 between the oral bisoprolol PO and intravenous diltiazem IV groups after 60 minutes
Study design This is a prospective single-blinded randomized controlled trial will be conducted as a single-centre investigation within the Emergency Department of Sultan Qaboos University Hospital SQUH This study will involve adult patients aged 18 and older and all eligible participants will be given written informed consent to join the research
Control Group Participants in this group will be administered a single intravenous dose of diltiazem at a dosage of 025 mgkg with a maximum dose capped at 30 mg
Intervention Group Participants in this group will receive a single oral dose of Bisoprolol set at a dosage of 5 mg with a maximum dose limit of 5 mg
Primary endpoints
The primary efficacy outcome evaluated by achieving a HR110 beats per minute or a decrease 20 of baseline HR at 60 minutes
The primary safety outcome measures were HR 60 bpm and SBP 95 mm Hg
Secondary endpoints
The use of Rescue medication Rescue rate control defined as the administration of a supplementary rate control medication after 60 minutes of the initial dose of the interventional drug
Proportion of patients who required hospitalization hospital admission ICU admission
ED revisit
Treatment-Related Adverse Events
Dizziness headaches gastrointestinal symptoms
Worsening of heart failure or pulmonary edema
Sample size
In addressing the novel concept of comparing the effectiveness of oral bisoprolol versus IV diltiazem in treating AF or Atrial Flatter with RVR in an acute setting we aim to conduct a pilot study with 30 patients in each group to calculate the study sample size
Study Procedures
1 Present to the Clinical Site
An eligible adult patient aged 18 years or older who presents with symptomatic rapid ventricular response atrial fibrillation or atrial flutter and requires treatment for rate control
2 Eligibility Assessments
Inclusion and exclusion criteria will be checked
3 Informed Consent
Potentially eligible participants will be identified by their treating clinicians Written informed consent to participate in this study will follow a process of information exchange between clinicians and potential participants
4 Study the effectiveness in achieving rate control
Data will be collected prospectively including demographics medical history vital signs and ECG results Each patient will be promptly assessed and continuous monitoring will be established for every patient to monitor cardiac rhythm heart rate HR blood pressure and oxygen saturation levels
Heart rate will be recorded every 15 mins till the 90 minutes mark
For the therapy to be considered effective the patients had to achieve a ventricular rate 110min or experience a drop-in ventricular rate of at least 20 at 60 minutes
12 lead ECG will be done every 30 minutes at 030 and 60 minutes
Relevant secondary outcomes will be recorded
5 Standard-of-Care Procedures
Patients may receive additional medications as part of their emergency department treatment after 60 minutes if patient remained hemodynamically stable Any additional medications administered will be recorded The need for additional medications including the drug administered the dose the time and the route of administration will be recorded
6 Safety Assessments
All adverse events will be documented on the adverse event case log Serious adverse events should be immediately reported to the primary investigator Any serious adverse event will be reported immediately to the Institutional Review Board An Adverse Event is considered serious if it causes a threat to the patients life or functioning The US Food and Drug Administration FDA defines a serious adverse event SAE as any untoward medical occurrence that
Results in death
Life threatening places the patient at risk of death
Requires hospitalization or prolongs an existing hospitalization
Causes persistent or significant disability or incapacity
Requires medical intervention to prevent one of the above outcomes
7 Follow UP All participant will be follow up after 24 hour and 48 houre
RISKS AND BENEFITS
Bisoprolol a cardioselective beta-1 adrenergic agent is recognized for its potency and the convenience of once-daily dosing It is well-tolerated and deemed suitable for patients with chronic bronchoconstrictive disease with safety established through clinical trials On the other hand diltiazem a calcium channel blocker is commonly used for hypertension and short-term AF management due to its rapid onset and lower impact on blood pressure making it suitable for emergencies
In collaboration with cardiology experts the designated 60-minute time frame has been established to balance clinical relevance with patient safety The administration of oral bisoprolol is considered a reliable and convenient treatment modality assumed to be fast painless and associated with a lower risk of complications This approach aims to facilitate a smooth transition to oral maintenance and provide an alternative for AF management in a busy Emergency Department Meanwhile intravenous IV diltiazem is acknowledged for its rapid onset rendering it effective for the treatment of symptomatic atrial fibrillation patients in the emergency department Throughout the ED phase each patient will undergo close monitoring to ensure their utmost safety
It is crucial to carefully consider the balance between potential benefits and risks particularly in cases involving heart failure patients Detailed monitoring protocols are in place to swiftly detect and manage any adverse effects or complications that may arise Our pre-emptive strategies include comprehensive and regular patient monitoring the implementation of an emergency protocol to address unexpected issues and a meticulous medication review prior to any treatment administration We are committed to transparent and ongoing communication with all study participants maintaining a continuous focus on safeguarding their health and ensuring that the potential advantages of participation outweigh the risks
Research Objectives and Hypothesis The research aims to test the null hypothesis which posits that there is no significant difference in achieving a heart rate HR below 110 beatsmin or a reduction in ventricular rate by at least 20 between the oral bisoprolol PO and intravenous diltiazem IV groups after 60 minutes
Study design This is a prospective single-blinded randomized controlled trial will be conducted as a single-centre investigation within the Emergency Department of Sultan Qaboos University Hospital SQUH This study will involve adult patients aged 18 and older and all eligible participants will be given written informed consent to join the research
Control Group Participants in this group will be administered a single intravenous dose of diltiazem at a dosage of 025 mgkg with a maximum dose capped at 30 mg
Intervention Group Participants in this group will receive a single oral dose of Bisoprolol set at a dosage of 5 mg with a maximum dose limit of 5 mg
Primary endpoints
The primary efficacy outcome evaluated by achieving a HR110 beats per minute or a decrease 20 of baseline HR at 60 minutes
The primary safety outcome measures were HR 60 bpm and SBP 95 mm Hg
Secondary endpoints
The use of Rescue medication Rescue rate control defined as the administration of a supplementary rate control medication after 60 minutes of the initial dose of the interventional drug
Proportion of patients who required hospitalization hospital admission ICU admission
ED revisit
Treatment-Related Adverse Events
Dizziness headaches gastrointestinal symptoms
Worsening of heart failure or pulmonary edema
Sample size
In addressing the novel concept of comparing the effectiveness of oral bisoprolol versus IV diltiazem in treating AF or Atrial Flatter with RVR in an acute setting we aim to conduct a pilot study with 30 patients in each group to calculate the study sample size
Study Procedures
1 Present to the Clinical Site
An eligible adult patient aged 18 years or older who presents with symptomatic rapid ventricular response atrial fibrillation or atrial flutter and requires treatment for rate control
2 Eligibility Assessments
Inclusion and exclusion criteria will be checked
3 Informed Consent
Potentially eligible participants will be identified by their treating clinicians Written informed consent to participate in this study will follow a process of information exchange between clinicians and potential participants
4 Study the effectiveness in achieving rate control
Data will be collected prospectively including demographics medical history vital signs and ECG results Each patient will be promptly assessed and continuous monitoring will be established for every patient to monitor cardiac rhythm heart rate HR blood pressure and oxygen saturation levels
Heart rate will be recorded every 15 mins till the 90 minutes mark
For the therapy to be considered effective the patients had to achieve a ventricular rate 110min or experience a drop-in ventricular rate of at least 20 at 60 minutes
12 lead ECG will be done every 30 minutes at 030 and 60 minutes
Relevant secondary outcomes will be recorded
5 Standard-of-Care Procedures
Patients may receive additional medications as part of their emergency department treatment after 60 minutes if patient remained hemodynamically stable Any additional medications administered will be recorded The need for additional medications including the drug administered the dose the time and the route of administration will be recorded
6 Safety Assessments
All adverse events will be documented on the adverse event case log Serious adverse events should be immediately reported to the primary investigator Any serious adverse event will be reported immediately to the Institutional Review Board An Adverse Event is considered serious if it causes a threat to the patients life or functioning The US Food and Drug Administration FDA defines a serious adverse event SAE as any untoward medical occurrence that
Results in death
Life threatening places the patient at risk of death
Requires hospitalization or prolongs an existing hospitalization
Causes persistent or significant disability or incapacity
Requires medical intervention to prevent one of the above outcomes
7 Follow UP All participant will be follow up after 24 hour and 48 houre
RISKS AND BENEFITS
Bisoprolol a cardioselective beta-1 adrenergic agent is recognized for its potency and the convenience of once-daily dosing It is well-tolerated and deemed suitable for patients with chronic bronchoconstrictive disease with safety established through clinical trials On the other hand diltiazem a calcium channel blocker is commonly used for hypertension and short-term AF management due to its rapid onset and lower impact on blood pressure making it suitable for emergencies
In collaboration with cardiology experts the designated 60-minute time frame has been established to balance clinical relevance with patient safety The administration of oral bisoprolol is considered a reliable and convenient treatment modality assumed to be fast painless and associated with a lower risk of complications This approach aims to facilitate a smooth transition to oral maintenance and provide an alternative for AF management in a busy Emergency Department Meanwhile intravenous IV diltiazem is acknowledged for its rapid onset rendering it effective for the treatment of symptomatic atrial fibrillation patients in the emergency department Throughout the ED phase each patient will undergo close monitoring to ensure their utmost safety
It is crucial to carefully consider the balance between potential benefits and risks particularly in cases involving heart failure patients Detailed monitoring protocols are in place to swiftly detect and manage any adverse effects or complications that may arise Our pre-emptive strategies include comprehensive and regular patient monitoring the implementation of an emergency protocol to address unexpected issues and a meticulous medication review prior to any treatment administration We are committed to transparent and ongoing communication with all study participants maintaining a continuous focus on safeguarding their health and ensuring that the potential advantages of participation outweigh the risks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None