Rate Control in Atrial Fibrillation | NCT02251509

Studies
Rate Control in Atrial Fibrillation

NCT02251509

Sponsor

Creighton University

Status

Unknown status

Last Update Posted

Jun 16, 2016Estimated

Enrollment

20Estimated

Phase

Phase 4

Conditions

Atrial Fibrillation

Interventions

Carvedilol
Metoprolol tartrate

Countries

United States

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

Jun 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Sep 2017Estimated

Completion Date

Sep 2017Estimated

First Submitted Date

Sep 25, 2014

First Submission Date that Met QC Criteria

Sep 25, 2014

First Posted Date

Sep 29, 2014Estimated

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

Jun 15, 2016

Last Update Posted Date

Jun 16, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will evaluate the efficacy of metoprolol tartrate compared to carvedilol on heart rate control in patients with atrial fibrillation and a rapid ventricular rate.

Detailed Description

Not provided

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Carvedilol	Experimental	carvedilol BID for 2 weeks	Drug: Carvedilol
Metoprolol tartrate	Experimental	Metoprolol tartrate BID for 2 weeks	Drug: Metoprolol tartrate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Carvedilol	Drug		Carvedilol	Coreg
Metoprolol tartrate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Resting heart rate	Resting heart rate less than 80 bpm	2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Permanent atrial fibrillation
Baseline ventricular rate (prior to treatment) > 110 bpm

Exclusion Criteria:

History of accessory tract re-entry tachycardia
Ejection fraction < 35% or history of NYHA Class III/IV stage C/D heart failure
Acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery in the past 2 months
Child-Pugh class B or C hepatic dysfunction
Uncontrolled hypertension
Thyroid disease
Intolerance to beta-blockers
History of lung disease resulting in hospitalization in the past year

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Caroline Nubel	Contact	(402) 280-4032		carolinenubel@creighton.edu

Overall Officials

Name	Affiliation	Role
Pallavi Bellamkonda, MBBS	Creighton University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Creighton University		Omaha	Nebraska	68178	United States

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077261	Carvedilol
D008790	Metoprolol

Ancestor Terms

ID	Term
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided