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| Sponsor: | Asker & Baerum Hospital |
|---|---|
| Information provided by: | Asker & Baerum Hospital |
| ClinicalTrials.gov Identifier: | NCT00313157 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Drug: Metoprolol, Verapamil, Diltiazem, Carvedilol. |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Crossover Assignment, Safety/Efficacy Study |
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | January 2008 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Sara Reinvik Fagertun, MD | 67809400 ext +47 | sara.fagertun@sabhf.no |
| Contact: Steve Enger, Study nurse | 67809400 ext +47 | steve.enger@sabhf.no |
| Norway, Akershus | |
| Asker and Baerum Hospital | Recruiting |
| Rud, Akershus, Norway, 1309 | |
| Contact: Sara Reinvik Fagertun, MD 67809400 ext +47 sara.fagertun@sabhf.no | |
| Contact: Steve Enger, Study nurse 67809400 ext +47 steve.enger@sabhf.no | |
| Principal Investigator: Sara Reinvik Fagertun, MD | |
| Principal Investigator: | Sara Reinvik Fagertun, MD | Asker and Baerum Hospital |
More Information
| Study ID Numbers: | 2005-004221-26 |
| Study First Received: | April 10, 2006 |
| Last Updated: | April 10, 2006 |
| ClinicalTrials.gov Identifier: | NCT00313157 History of Changes |
| Health Authority: | Norway: Norwegian Medicines Agency |
|
Atrial fibrillation |
|
Vasodilator Agents Sympatholytics Neurotransmitter Agents Heart Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic alpha-Antagonists Cardiovascular Agents Antihypertensive Agents Metoprolol Pharmacologic Actions |
Pathologic Processes Autonomic Agents Therapeutic Uses Adrenergic beta-Antagonists Cardiovascular Diseases Adrenergic Antagonists Peripheral Nervous System Agents Anti-Arrhythmia Agents Atrial Fibrillation Arrhythmias, Cardiac Carvedilol |
