RATe Control in Atrial Fibrillation

Study Overview
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Brief Summary
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The purpose of this study is to compare the effect of metoprolol, verapamil, diltiazem and carvedilol on ventricular rate, working capacity and quality of life in patients with chronic atrial fibrillation.

Detailed Description
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This is a randomised, single blinded, cross-over study comparing the efficacy of metoprolol 100 mg o.d., verapamil 240 mg o.d., diltiazem 360 mg o.d. and carvedilol 25 mg o.d. in reducing ventricular rate in atrial fibrillation. A total of 60 patients will be included, with a minimum of 20 women.Patients will receive each of the drug regimens in a random sequence. Each regimen will be administered for 3 weeks, ensuring that steady-state drug concentration will be attained and to provide an adequate washout of the previous treatment. Following each regimen, exercise ECG and Holter registration will be performed and patients will undergo laboratory evaluation and complete QoL-forms. They will then be started on the next randomly assigned treatment regimen, until the entire sequence of treatment schedules is completed.

Official Title
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Rate Control in Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Metoprolol
* Drug: Diltiazem
* Drug: Verapamil
* Drug: Carvedilol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persistent or permanent atrial fibrillation with ventricular rate > 80/min at rest and/or > 100/min average at daytime. Male or female, age > 18. Exclusion Criteria: Hypersensitivity or contraindication to metoprolol, verapamil, diltiazem or carvedilol. Coronary heart disease or heart failure Systolic blood pressure < 100 mmHg AV-conduction disturbance Severe hepatic or renal dysfunction Thyrotoxicosis Ongoing treatment with Digitalis Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metoprolol<br>Treatment with Metoprolol 100 mg x 1 for three weeks | Drug: Metoprolol<br> <br> * Other names: Selo-Zok;|
| Active Comparator: Diltiazem<br>Treatment with Diltiazem 360 mg x 1 for three weeks | Drug: Diltiazem<br> <br> * Other names: Cardizem;|
| Active Comparator: Verapamil<br>Treatment with Verapamil 240 mg x 1 for three weeks | Drug: Verapamil<br> <br> * Other names: Isoptin Retard;|
| Active Comparator: Carvedilol<br>Treatment with Carvedilol 25 mg x 1 for three weeks | Drug: Carvedilol<br> <br> * Other names: Kredex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular rate | Ventricular rate evaluated after three weeks on study drug treatment | Three weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation