RATAF -RATe Control in Atrial Fibrillation
Recruitment status was Active, not recruiting
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind Primary Purpose: Treatment |
- Ventricular rate (daytime)
- Working capacity
- Quality of Life
| Enrollment: | 80 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | March 2011 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
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:
- 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| Norway | |
| Vestre Viken Hospital Trust, Baerum Hospital | |
| Rud, Akershus, Norway, 1309 | |
| Principal Investigator: | Sara Reinvik Fagertun, MD | Asker and Baerum Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00313157 History of Changes |
| Other Study ID Numbers: | 2005-004221-26 |
| Study First Received: | April 10, 2006 |
| Last Updated: | December 21, 2010 |
| Health Authority: | Norway: Norwegian Medicines Agency |
Keywords provided by Asker & Baerum Hospital:
|
Atrial fibrillation |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Metoprolol Verapamil Carvedilol Diltiazem Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions 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 Calcium Channel Blockers Membrane Transport Modulators Vasodilator Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013