Carvedilol for Prevention of Paroxysmal Atrial Fibrillation

NCT01608893 | Unknown DMC

• 1 other identifier: Carvedilol for PAF
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation (AF) is the most common sustained heart rhythm disorder and is associated with significant symptoms and health problems including an increased risk of stroke and death. Current drug therapies are often ineffective and associated with significant side effects. Abnormalities of calcium regulation in cells may lead to triggers for AF. Emerging data suggest that abnormal intracellular calcium regulation mediated through the ryanodine receptor in heart cells may contribute to AF. Recently the investigators have shown that the β-blocker carvedilol which is most commonly used to treat patients with heart failure, modifies calcium regulation mediated through the ryanodine receptor. At present this drug is not frequently used to treat AF. Therefore the investigators will conduct a randomized trial comparing carvedilol to metoprolol for prevention of paroxysmal AF. This may result in improved health and quality of life for people who suffer AF.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Event-free survival to first detected AF after the one month blanking period for dose titration

  Time to first AF detected by event recorder transmission will be determined.

  1 year

Secondary Outcomes (7)

• number of Emergency room visits/hospitalizations for cardiovascular causes

  1 year

• Proportion of patients who develop persistent AF

  1 year

• Days in symptomatic AF/Time between successive PAF episodes

  1 year

• AF Severity Scale

  1 year

• Adverse effects of assigned therapy

  1 year

Study Arms (2)

Metoprolol

ACTIVE COMPARATOR

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.

Drug: Metoprolol

Carvedilol

ACTIVE COMPARATOR

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.

Drug: Carvedilol

Interventions

Carvedilol DRUG

6.25 po bid titrated to 25 mg bid as tolerated over a 1 month period

Also known as: Coreg

Carvedilol

Metoprolol DRUG

titrated to 50 mg po bid as tolerated over a 1 month period

Also known as: Lopressor

Metoprolol

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be in sinus rhythm at enrollment
• ECG documented symptomatic PAF (\> 2 episodes of \> 15minutes duration over a 6 month period)

You may not qualify if:

• AF due to reversible causes
• Contraindication or previous significant adverse reaction to Beta blocker therapy
• Persistent AF
• NYHA Class II or greater CHF
• LVEF \< or = 35%
• Life expectancy \< 1 year
• Geographic isolation
• Unable to give informed consent

Sponsors & Collaborators

• University of Calgary: lead
• Heart and Stroke Foundation of Canada: collaborator
• Libin Cardiovascular Institute of Alberta: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Carvedilol; Metoprolol

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Phenoxypropanolamines

Study Officials

• Anne M Gillis, M.D.

  Professor of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 28, 2012
• First Posted: May 31, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

CA (1)