NCT02251509

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4 atrial-fibrillation

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2014

Completed
2.2 years until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

June 16, 2016

Status Verified

June 1, 2016

Enrollment Period

9 months

First QC Date

September 25, 2014

Last Update Submit

June 15, 2016

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Resting heart rate

    Resting heart rate less than 80 bpm

    2 weeks

Study Arms (2)

Carvedilol

EXPERIMENTAL

carvedilol BID for 2 weeks

Drug: Carvedilol

Metoprolol tartrate

EXPERIMENTAL

Metoprolol tartrate BID for 2 weeks

Drug: Metoprolol tartrate

Interventions

CarvedilolDRUG
Also known as: Coreg
Carvedilol
Metoprolol tartrateDRUG
Also known as: Lopressor
Metoprolol tartrate

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68178, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

CarvedilolMetoprolol

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-RingPhenoxypropanolamines

Study Officials

  • Pallavi Bellamkonda, MBBS

    Creighton University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Nubel

CONTACT

(402) 280-4032carolinenubel@creighton.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2014

First Posted

September 29, 2014

Study Start

December 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

June 16, 2016

Record last verified: 2016-06

Locations

US(1)