RATAF -RATe Control in Atrial Fibrillation
Information source: Asker & Baerum Hospital
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation
Intervention: Metoprolol, Verapamil, Diltiazem, Carvedilol. (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Asker & Baerum Hospital Official(s) and/or principal investigator(s):
Sara Reinvik Fagertun, MD, Principal Investigator, Affiliation: Asker and Baerum Hospital
Overall contact:
Sara Reinvik Fagertun, MD, Phone: 67809400, Ext: +47, Email: sara.fagertun@sabhf.no
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.
Clinical Details
Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment
Primary outcome: Ventricular rate (daytime)Working capacity Quality of Life
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Sara Reinvik Fagertun, MD, Phone: 67809400, Ext: +47, Email: sara.fagertun@sabhf.no
Asker and Baerum Hospital, Rud, Akershus 1309, Norway; Recruiting
Sara Reinvik Fagertun, MD, Phone: 67809400, Ext: +47, Email: sara.fagertun@sabhf.no
Steve Enger, Study nurse, Phone: 67809400, Ext: +47, Email: steve.enger@sabhf.no
Sara Reinvik Fagertun, MD, Principal Investigator
Additional Information
Starting date: April 2006
Last updated: April 10, 2006
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