RATe Control in Atrial Fibrillation (RATAF)
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| ClinicalTrials.gov Identifier: NCT00313157 |
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Recruitment Status :
Completed
First Posted : April 12, 2006
Last Update Posted : May 13, 2014
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Sponsor:
Asker & Baerum Hospital
Information provided by (Responsible Party):
Sara Reinvik Ulimoe, Asker & Baerum Hospital
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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 |
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 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
MedlinePlus Genetics related topics:
Familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
Drug Information available for:
Diltiazem
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Metoprolol
Treatment with Metoprolol 100 mg x 1 for three weeks
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Drug: Metoprolol
Other Name: Selo-Zok |
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Active Comparator: Diltiazem
Treatment with Diltiazem 360 mg x 1 for three weeks
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Drug: Diltiazem
Other Name: Cardizem |
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Active Comparator: Verapamil
Treatment with Verapamil 240 mg x 1 for three weeks
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Drug: Verapamil
Other Name: Isoptin Retard |
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Active Comparator: Carvedilol
Treatment with Carvedilol 25 mg x 1 for three weeks
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Drug: Carvedilol
Other Name: Kredex |
Primary Outcome Measures :
- Ventricular rate [ Time Frame: Three weeks ]Ventricular rate evaluated after three weeks on study drug treatment
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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
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
| Norway | |
| Vestre Viken Hospital Trust, Baerum Hospital | |
| Rud, Akershus, Norway, 1309 | |
Sponsors and Collaborators
Asker & Baerum Hospital
Investigators
| Principal Investigator: | Sara Reinvik Fagertun, MD | Asker and Baerum Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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:
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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 |