RATAF -RATe Control in Atrial Fibrillation - Full Text View

Sponsor:	Asker & Baerum Hospital
Information provided by:	Asker & Baerum Hospital
ClinicalTrials.gov Identifier:	NCT00313157

Purpose

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.

Condition	Intervention	Phase
Atrial Fibrillation	Drug: Metoprolol, Verapamil, Diltiazem, Carvedilol.	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: Verapamil Diltiazem hydrochloride Dexverapamil Diltiazem Metoprolol Metoprolol Tartrate Carvedilol Metoprolol succinate Metoprolol fumarate Diltiazem malate Verapamil hydrochloride

U.S. FDA Resources

Further study details as provided by Asker & Baerum Hospital:

Primary Outcome Measures:

Ventricular rate (daytime)
Working capacity
Quality of Life

Enrollment:	80
Study Start Date:	April 2006
Estimated Study Completion Date:	March 2011
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313157

Locations

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

Sponsors and Collaborators

Asker & Baerum Hospital

Investigators

Principal Investigator:

Sara Reinvik Fagertun, MD

Asker and Baerum Hospital

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00313157 History of Changes
Other Study ID Numbers:	2005-004221-26
Study First Received:	April 10, 2006
Last Updated:	December 21, 2010
Health Authority:	Norway: Norwegian Medicines Agency

Keywords provided by Asker & Baerum Hospital:

Atrial fibrillation

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Metoprolol
Verapamil
Carvedilol
Diltiazem
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on February 09, 2012