RAte Control Efficacy in Permanent Atrial Fibrillation | NCT00392613

Studies
RAte Control Efficacy in Permanent Atrial Fibrillation

NCT00392613

Sponsor

University Medical Center Groningen

Status

Completed

Last Update Posted

Jan 7, 2010Estimated

Enrollment

500Estimated

Phase

Not Applicable

Conditions

Persistent Atrial Fibrillation

Interventions

Strict versus lenient rate control

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Dec 2009Actual

Completion Date

Not provided

First Submitted Date

Oct 25, 2006

First Submission Date that Met QC Criteria

Oct 25, 2006

First Posted Date

Oct 26, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2010

Last Update Posted Date

Jan 7, 2010Estimated

Name	Class
Netherlands Heart Foundation	OTHER

Description Module

Brief Summary

The investigators hypothesis is that in patients with permanent AF lenient rate control is not inferior to strict rate control in terms of cardiovascular mortality, morbidity, neurohormonal activation, NYHA class for heart failure, left ventricular function, left atrial size, quality of life and costs. Lenient rate control is defined as a resting heart rate <110 bpm.Strict rate control is defined as a mean resting heart rate < 80 beats per minute (bpm) and heart rate during minor exercise < 110 bpm. Patients will be seen after 1, 2, 3 months (for titration of rate control drugs) and thereafter yearly.

Detailed Description

Study objectives:

To show that lenient rate control is not inferior to strict rate control in terms of cardiovascular mortality and morbidity
To show that lenient rate control is not inferior to strict rate control in terms of all cause mortality, cardiovascular hospitalizations, NYHA class for exercise tolerance, left ventricular function and left atrial size, quality of life, neurohormonal activation as measured by NT-proBNP, hospitalization for heart failure, syncope, sustained ventricular tachycardia, appropriate shocks or anti-tachycardia pacing of ICD for ventricular arrhythmias, cardiac arrest, and pacemaker implantations, stroke, systemic emboli, and bleeding, unstable angina pectoris and myocardial infarction, costs and renal function

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Name	Type	Description	Arm Group Labels	Other Names
Strict versus lenient rate control	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiovascular mortality
Heart failure
Stroke
Bleeding
Syncope
Ventricular tachycardia
PM / ICD implantation
Cardiac arrest
Life-threatening adverse effects of RC drugs

Secondary Outcomes

Measure	Description	Time Frame
All cause mortality
All cause hospitalizations
Exercise tolerance

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a current episode of permanent AF < 12 months.
Age </= 80 years.
Mean resting heart rate > 80 beats per minute with or without rate control medication
Oral anticoagulation (or aspirin if no risk factors for thromboembolic complications are present).

Exclusion Criteria:

Paroxysmal AF
Known contra-indications for either strict or lenient rate control (e.g. previous adverse effects on negative chronotropic drugs).
Unstable heart failure defined as NYHA IV heart failure and heart failure necessitating hospital admission < 3 months before inclusion.
Cardiac surgery < 3 months.
Any stroke.
Current or foreseen pacemaker and/ or cardiac resynchronization therapy.
Signs of sick sinus syndrome or AV conduction disturbances (i.e. symptomatic bradycardia or asystole > 3 seconds or escape rate < 40 beats per minute in awake symptom-free patients).
Untreated hyperthyroidism or < 3 months euthyroidism.
Inability to walk or bike.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Isabelle C Van Gelder, MD	University Medical Center Groningen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Groningen		Groningen		9700RB	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21996393	Derived	Groenveld HF, Crijns HJ, Van den Berg MP, Van Sonderen E, Alings AM, Tijssen JG, Hillege HL, Tuininga YS, Van Veldhuisen DJ, Ranchor AV, Van Gelder IC; RACE II Investigators. The effect of rate control on quality of life in patients with permanent atrial fibrillation: data from the RACE II (Rate Control Efficacy in Permanent Atrial Fibrillation II) study. J Am Coll Cardiol. 2011 Oct 18;58(17):1795-803. doi: 10.1016/j.jacc.2011.06.055.
21851883

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes