Carvedilol for Prevention of Paroxysmal Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT01608893|
Recruitment Status : Recruiting
First Posted : May 31, 2012
Last Update Posted : October 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: Carvedilol Drug: Metoprolol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Carvedilol for Prevention of Paroxysmal Atrial Fibrillation|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Active Comparator: Metoprolol
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.
titrated to 50 mg po bid as tolerated over a 1 month period
Other Name: Lopressor
Active Comparator: Carvedilol
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.
6.25 po bid titrated to 25 mg bid as tolerated over a 1 month period
Other Name: Coreg
- Event-free survival to first detected AF after the one month blanking period for dose titration [ Time Frame: 1 year ]Time to first AF detected by event recorder transmission will be determined.
- number of Emergency room visits/hospitalizations for cardiovascular causes [ Time Frame: 1 year ]Subjects will be questioned via telephone interview or clinic visit every 3 months and appropriate hospital recorders retrieved for confirmation of event.
- Proportion of patients who develop persistent AF [ Time Frame: 1 year ]
- Days in symptomatic AF/Time between successive PAF episodes [ Time Frame: 1 year ]The days in which patients report symptomatic AF confirmed by event recorder transmission will be determined and the time interval between successive events will be determined.
- AF Severity Scale [ Time Frame: 1 year ]Measured via University of Toronto AF Severity Scale at baseline and at end of study or study exit
- Adverse effects of assigned therapy [ Time Frame: 1 year ]Adverse effects thought to be related to drug therapy will be documented as well as number of patients in whom drug is discontined because of adverse events.
- Ventricular rate during AF [ Time Frame: 1 year ]Ventricular rate during AF will be measured from the event recorder tracings - from 10 sec of recording
- CCS AF Symptom Score [ Time Frame: 1 yr ]
This will be determined from interview at baseline and each follow-up visit. The CCS AF symptom score is a 5 point score from 0 to 4.
CCS-SAF Class Definitions
Class 0 Asymptomatic with respect to AF Class 1 Symptoms attributable to AF have minimal effect on patient's general QOL.
Class 2 Symptoms attributable to AF have a minor effect on patient's general QOL.
Class 3 Symptoms attributable to AF have a moderate effect on patient's general QOL.
Class 4 Symptoms attributable to AF have a severe effect on patient's general QOL.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608893
|Contact: Anne M Gillis, M.D.||firstname.lastname@example.org|
|Contact: Jennifer McKeage, R.N.||email@example.com|
|University of Calgary||Recruiting|
|Calgary, Alberta, Canada, T2N 4Z6|
|Contact: Anne Gillis|
|Contact: Jennifer McKeage|
|Principal Investigator: Anne M Gillis, M.D.|
|Sub-Investigator: Henry Duff, M.D.|
|Sub-Investigator: Derek Exner, M.D.|
|Sub-Investigator: Katherine Kavanagh, M.D.|
|Sub-Investigator: Vikas Kuriachan, M.D.|
|Sub-Investigator: Brent Mitchell, M.D.|
|Sub-Investigator: Timothy Pollack, M.D.|
|Sub-Investigator: Russell Quinn, M.D.|
|Sub-Investigator: Robert Sheldon, M.D.|
|Sub-Investigator: Glen Sumner, M.D.|
|Sub-Investigator: George Veenhuyzen, M.D.|
|Sub-Investigator: Stephen Wilton, M.D.|
|Sub-Investigator: George Wyse, M.D.|
|Principal Investigator:||Anne M Gillis, M.D.||Professor of Medicine|