Rate Control in Atrial Fibrillation

June 15, 2016 updated by: Creighton University

Rate Control in Atrial Fibrillation: A Randomized, Double-Blind, Crossover Comparison of Carvedilol and Metoprolol Tartrate

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68178
        • Creighton University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carvedilol
carvedilol BID for 2 weeks
Drug: Carvedilol
Other Names:
  • Coreg
Experimental: Metoprolol tartrate
Metoprolol tartrate BID for 2 weeks
Drug: Metoprolol tartrate
Other Names:
  • Lopressor

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creighton University

Investigators

  • Principal Investigator: Pallavi Bellamkonda, MBBS, Creighton University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

September 25, 2014

First Submitted That Met QC Criteria

September 25, 2014

First Posted (Estimate)

September 29, 2014

Study Record Updates

Last Update Posted (Estimate)

June 16, 2016

Last Update Submitted That Met QC Criteria

June 15, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 624918

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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