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RATe Control in Atrial Fibrillation (RATAF)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Metoprolol
Diltiazem
Verapamil
Carvedilol
Sponsored by
Asker & Baerum Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Vestre Viken Hospital Trust, Baerum Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Metoprolol

Diltiazem

Verapamil

Carvedilol

Arm Description

Treatment with Metoprolol 100 mg x 1 for three weeks

Treatment with Diltiazem 360 mg x 1 for three weeks

Treatment with Verapamil 240 mg x 1 for three weeks

Treatment with Carvedilol 25 mg x 1 for three weeks

Outcomes

Primary Outcome Measures

Ventricular rate
Ventricular rate evaluated after three weeks on study drug treatment

Secondary Outcome Measures

Full Information

First Posted
April 10, 2006
Last Updated
May 11, 2014
Sponsor
Asker & Baerum Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00313157
Brief Title
RATe Control in Atrial Fibrillation
Acronym
RATAF
Official Title
Rate Control in Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asker & Baerum Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metoprolol
Arm Type
Active Comparator
Arm Description
Treatment with Metoprolol 100 mg x 1 for three weeks
Arm Title
Diltiazem
Arm Type
Active Comparator
Arm Description
Treatment with Diltiazem 360 mg x 1 for three weeks
Arm Title
Verapamil
Arm Type
Active Comparator
Arm Description
Treatment with Verapamil 240 mg x 1 for three weeks
Arm Title
Carvedilol
Arm Type
Active Comparator
Arm Description
Treatment with Carvedilol 25 mg x 1 for three weeks
Intervention Type
Drug
Intervention Name(s)
Metoprolol
Other Intervention Name(s)
Selo-Zok
Intervention Type
Drug
Intervention Name(s)
Diltiazem
Other Intervention Name(s)
Cardizem
Intervention Type
Drug
Intervention Name(s)
Verapamil
Other Intervention Name(s)
Isoptin Retard
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Other Intervention Name(s)
Kredex
Primary Outcome Measure Information:
Title
Ventricular rate
Description
Ventricular rate evaluated after three weeks on study drug treatment
Time Frame
Three weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Reinvik Fagertun, MD
Organizational Affiliation
Asker and Baerum Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vestre Viken Hospital Trust, Baerum Hospital
City
Rud
State/Province
Akershus
ZIP/Postal Code
1309
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
27142292
Citation
Horjen AW, Ulimoen SR, Enger S, Norseth J, Seljeflot I, Arnesen H, Tveit A. Troponin I levels in permanent atrial fibrillation-impact of rate control and exercise testing. BMC Cardiovasc Disord. 2016 May 4;16:79. doi: 10.1186/s12872-016-0255-x.
Results Reference
derived
PubMed Identifier
25362163
Citation
Corino VD, Sandberg F, Platonov PG, Mainardi LT, Ulimoen SR, Enger S, Tveit A, Sornmo L. Non-invasive evaluation of the effect of metoprolol on the atrioventricular node during permanent atrial fibrillation. Europace. 2014 Nov;16 Suppl 4:iv129-iv134. doi: 10.1093/europace/euu246.
Results Reference
derived
PubMed Identifier
24700386
Citation
Ulimoen SR, Enger S, Norseth J, Pripp AH, Abdelnoor M, Arnesen H, Gjesdal K, Tveit A. Improved rate control reduces cardiac troponin T levels in permanent atrial fibrillation. Clin Cardiol. 2014 Jul;37(7):422-7. doi: 10.1002/clc.22281. Epub 2014 Apr 3.
Results Reference
derived

Learn more about this trial

RATe Control in Atrial Fibrillation

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