NCT00313157

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3 atrial-fibrillation

Timeline
Completed

Started Apr 2006

Typical duration for phase_3 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2006

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

May 13, 2014

Status Verified

May 1, 2014

Enrollment Period

4.4 years

First QC Date

April 10, 2006

Last Update Submit

May 11, 2014

Conditions

Keywords

Atrial fibrillation

Outcome Measures

Primary Outcomes (1)

  • Ventricular rate

    Ventricular rate evaluated after three weeks on study drug treatment

    Three weeks

Study Arms (4)

Metoprolol

ACTIVE COMPARATOR

Treatment with Metoprolol 100 mg x 1 for three weeks

Drug: Metoprolol

Diltiazem

ACTIVE COMPARATOR

Treatment with Diltiazem 360 mg x 1 for three weeks

Drug: Diltiazem

Verapamil

ACTIVE COMPARATOR

Treatment with Verapamil 240 mg x 1 for three weeks

Drug: Verapamil

Carvedilol

ACTIVE COMPARATOR

Treatment with Carvedilol 25 mg x 1 for three weeks

Drug: Carvedilol

Interventions

Also known as: Selo-Zok
Metoprolol
Also known as: Cardizem
Diltiazem
Also known as: Isoptin Retard
Verapamil
Also known as: Kredex
Carvedilol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persistent or permanent atrial fibrillation with ventricular rate \> 80/min at rest and/or \> 100/min average at daytime.
  • Male or female, age \> 18.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vestre Viken Hospital Trust, Baerum Hospital

Rud, Akershus, 1309, Norway

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

MetoprololDiltiazemVerapamilCarvedilol

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPhenethylaminesEthylaminesCarbazolesIndolesHeterocyclic Compounds, 3-Ring

Study Officials

  • Sara Reinvik Fagertun, MD

    Asker and Baerum Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 10, 2006

First Posted

April 12, 2006

Study Start

April 1, 2006

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

May 13, 2014

Record last verified: 2014-05

Locations