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Rate Control in Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Carvedilol
Metoprolol tartrate
Sponsored by
Creighton University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Creighton University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Carvedilol

Metoprolol tartrate

Arm Description

carvedilol BID for 2 weeks

Metoprolol tartrate BID for 2 weeks

Outcomes

Primary Outcome Measures

Resting heart rate
Resting heart rate less than 80 bpm

Secondary Outcome Measures

Full Information

First Posted
September 25, 2014
Last Updated
June 15, 2016
Sponsor
Creighton University
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1. Study Identification

Unique Protocol Identification Number
NCT02251509
Brief Title
Rate Control in Atrial Fibrillation
Official Title
Rate Control in Atrial Fibrillation: A Randomized, Double-Blind, Crossover Comparison of Carvedilol and Metoprolol Tartrate
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Creighton University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carvedilol
Arm Type
Experimental
Arm Description
carvedilol BID for 2 weeks
Arm Title
Metoprolol tartrate
Arm Type
Experimental
Arm Description
Metoprolol tartrate BID for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Other Intervention Name(s)
Coreg
Intervention Type
Drug
Intervention Name(s)
Metoprolol tartrate
Other Intervention Name(s)
Lopressor
Primary Outcome Measure Information:
Title
Resting heart rate
Description
Resting heart rate less than 80 bpm
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Nubel
Phone
(402) 280-4032
Email
carolinenubel@creighton.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pallavi Bellamkonda, MBBS
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68178
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Nubel
Phone
402-280-4032
Email
carolinenubel@creighton.edu
First Name & Middle Initial & Last Name & Degree
Pallavi Bellamkonda, MBBS

12. IPD Sharing Statement

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Rate Control in Atrial Fibrillation

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