RATe Control in Atrial Fibrillation (RATAF)

May 11, 2014 updated by: Sara Reinvik Ulimoe, Asker & Baerum Hospital

Rate Control in Atrial Fibrillation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Akershus
      • Rud, Akershus, Norway, 1309
        • Vestre Viken Hospital Trust, Baerum Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Metoprolol
Treatment with Metoprolol 100 mg x 1 for three weeks
Drug: Metoprolol
Other Names:
  • Selo-Zok
Active Comparator: Diltiazem
Treatment with Diltiazem 360 mg x 1 for three weeks
Drug: Diltiazem
Other Names:
  • Cardizem
Active Comparator: Verapamil
Treatment with Verapamil 240 mg x 1 for three weeks
Drug: Verapamil
Other Names:
  • Isoptin Retard
Active Comparator: Carvedilol
Treatment with Carvedilol 25 mg x 1 for three weeks
Drug: Carvedilol
Other Names:
  • Kredex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventricular rate
Time Frame: Three weeks
Ventricular rate evaluated after three weeks on study drug treatment
Three weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asker & Baerum Hospital

Investigators

  • Principal Investigator: Sara Reinvik Fagertun, MD, Asker and Baerum Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

April 10, 2006

First Submitted That Met QC Criteria

April 10, 2006

First Posted (Estimate)

April 12, 2006

Study Record Updates

Last Update Posted (Estimate)

May 13, 2014

Last Update Submitted That Met QC Criteria

May 11, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-004221-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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