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RATe Control in Atrial Fibrillation (RATAF)

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ClinicalTrials.gov Identifier: NCT00313157
Recruitment Status : Completed
First Posted : April 12, 2006
Last Update Posted : May 13, 2014
Sponsor:
Information provided by (Responsible Party):
Sara Reinvik Ulimoe, Asker & Baerum Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Metoprolol Drug: Diltiazem Drug: Verapamil Drug: Carvedilol Phase 3

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Rate Control in Atrial Fibrillation
Study Start Date : April 2006
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Diltiazem

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Metoprolol
Treatment with Metoprolol 100 mg x 1 for three weeks
 Drug: Metoprolol
Other Name: Selo-Zok
Active Comparator: Diltiazem
Treatment with Diltiazem 360 mg x 1 for three weeks
 Drug: Diltiazem
Other Name: Cardizem
Active Comparator: Verapamil
Treatment with Verapamil 240 mg x 1 for three weeks
 Drug: Verapamil
Other Name: Isoptin Retard
Active Comparator: Carvedilol
Treatment with Carvedilol 25 mg x 1 for three weeks
 Drug: Carvedilol
Other Name: Kredex


Outcome Measures
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Primary Outcome Measures :
  1. Ventricular rate [ Time Frame: Three weeks ]
    Ventricular rate evaluated after three weeks on study drug treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313157


Locations
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Norway
Vestre Viken Hospital Trust, Baerum Hospital
Rud, Akershus, Norway, 1309
Sponsors and Collaborators
Asker & Baerum Hospital
Investigators
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Principal Investigator: Sara Reinvik Fagertun, MD Asker and Baerum Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sara Reinvik Ulimoe, MD, Asker & Baerum Hospital
ClinicalTrials.gov Identifier: NCT00313157    
Other Study ID Numbers: 2005-004221-26
First Posted: April 12, 2006    Key Record Dates
Last Update Posted: May 13, 2014
Last Verified: May 2014
Keywords provided by Sara Reinvik Ulimoe, Asker & Baerum Hospital:
Atrial fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Metoprolol
Verapamil
Carvedilol
Diltiazem
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists