Clinical trial NCT00313157: RATe Control in Atrial Fibrillation
Official title: Rate Control in Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Lead sponsor: Asker & Baerum Hospital
Sponsor class: OTHER
First posted: 2006-04-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Ventricular rate
timeFrame: Three weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rud
country: Norway
facility: Vestre Viken Hospital Trust, Baerum Hospital
state: Akershus
Study officials:
affiliation: Asker and Baerum Hospital
name: Sara Reinvik Fagertun, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.