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Beta Blocker
Carvedilol for Atrial Fibrillation
N/A
Waitlist Available
Led By Anne M Gillis, M.D.
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
NYHA Class II or greater CHF
Unable to give informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare the effectiveness of two drugs, carvedilol and metoprolol, in preventing a heart rhythm disorder called atrial fibrillation.
Who is the study for?
This trial is for people with a heart rhythm disorder called paroxysmal atrial fibrillation, who've had symptoms recently. They must be able to consent and not have other serious heart conditions or life-threatening illnesses. It's not for those who can't take beta blockers due to past bad reactions.
What is being tested?
The study compares two drugs, Carvedilol and Metoprolol, to see which one is better at preventing episodes of irregular heartbeat in patients with atrial fibrillation. Participants will be randomly assigned to receive one of the two medications.
What are the potential side effects?
Possible side effects from both Carvedilol and Metoprolol include dizziness, fatigue, low blood pressure, slow heartbeat, and digestive issues. Each person may experience these differently.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have heart failure that affects my daily activities.
Select...
I am unable to understand and agree to the study's details on my own.
Select...
I cannot take Beta blockers due to severe side effects or other medical reasons.
Select...
My atrial fibrillation is caused by a condition that can be treated or reversed.
Select...
I have ongoing atrial fibrillation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Event-free survival to first detected AF after the one month blanking period for dose titration
Secondary study objectives
AF Severity Scale
Adverse effects of assigned therapy
CCS AF Symptom Score
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: MetoprololActive Control1 Intervention
The metoprolol arm patients are stratified by the arrhythmia management strategy Rate or Rhythm control and metoprolol is dose titrated from 25 mg bid to a maximum of 50 mg bid over one month then patients are followed for 6 months.
Group II: CarvedilolActive Control1 Intervention
The carvedilol arm patients are stratified by the arrhythmia management strategy Rate or Rhythm control and carvedilol is dose titrated from 3.25 mg bid to maximum dose of 25 mg bid over one month then patients are followed for 6 months.
Find a Location
Who is running the clinical trial?
University of CalgaryLead Sponsor
810 Previous Clinical Trials
885,994 Total Patients Enrolled
11 Trials studying Atrial Fibrillation
2,166 Patients Enrolled for Atrial Fibrillation
Libin Cardiovascular Institute of AlbertaOTHER
3 Previous Clinical Trials
348 Total Patients Enrolled
Heart and Stroke Foundation of CanadaOTHER
130 Previous Clinical Trials
72,491 Total Patients Enrolled
7 Trials studying Atrial Fibrillation
5,439 Patients Enrolled for Atrial Fibrillation
Anne M Gillis, M.D.Principal InvestigatorProfessor of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have heart failure that affects my daily activities.You live in a place that is far away from other people or services.You are not expected to live for more than 1 year.I am unable to understand and agree to the study's details on my own.I cannot take Beta blockers due to severe side effects or other medical reasons.Your heart must be in a normal rhythm when you join the study.My atrial fibrillation is caused by a condition that can be treated or reversed.Your heart is not pumping blood effectively, with a measurement of 35% or less.You have had more than two episodes of symptomatic atrial fibrillation that lasted for more than 15 minutes each time, as shown on an ECG test.I have ongoing atrial fibrillation.
Research Study Groups:
This trial has the following groups:- Group 1: Metoprolol
- Group 2: Carvedilol
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.