RATe Control in Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— RATAF  

Official title:

Rate Control in Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00313157
• Other study ID #: 2005-004221-26
• Status: Completed
• Phase: Phase 3
• First received: April 10, 2006
• Last updated: May 11, 2014
• Start date: April 2006
• Est. completion date: September 2010

Study information

• Verified date: May 2014
• Source: Asker & Baerum Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Metoprolol

• Diltiazem

• Verapamil

• Carvedilol

Locations

Country	Name	City	State
Norway	Vestre Viken Hospital Trust, Baerum Hospital	Rud	Akershus

Sponsors (1)

Lead Sponsor	Collaborator
Asker & Baerum Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventricular rate	Ventricular rate evaluated after three weeks on study drug treatment	Three weeks	No