RATe Control in Atrial Fibrillation (RATAF)

Asker & Baerum Hospital

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation

Treatments: Drug: Carvedilol; Drug: Verapamil; Drug: Diltiazem; Drug: Metoprolol

Study type: Interventional

Funder types: Other

Identifiers

NCT00313157

2005-004221-26

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

80 participants in 4 patient groups

Metoprolol

Active Comparator group

Description:

Treatment with Metoprolol 100 mg x 1 for three weeks

Treatment:

Drug: Metoprolol

Diltiazem

Active Comparator group

Description:

Treatment with Diltiazem 360 mg x 1 for three weeks

Treatment:

Drug: Diltiazem

Verapamil

Active Comparator group

Description:

Treatment with Verapamil 240 mg x 1 for three weeks

Treatment:

Drug: Verapamil

Carvedilol

Active Comparator group

Description:

Treatment with Carvedilol 25 mg x 1 for three weeks

Treatment:

Drug: Carvedilol