NCT01655303

Brief Summary

Rate control in atrial fibrillation is a usual battle in emergency departments. Oral medications have a natural superiority to intravenous ones because they are easy-to-use and decrease the workload in busy emergency departments. This study wants to find an effective oral medication for rate control in rapid ventricular response atrial fibrillation. Propranolol and Metoprolol, Diltiazem and Verapamil are compared in patients with a stable hemodynamic status.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2012

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

10 months

First QC Date

July 30, 2012

Last Update Submit

July 30, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate less than 100 per minute

    Ventricular rate less than 100 per minute after 1 hour of per oral medication administration

    In 1 hour

Secondary Outcomes (2)

  • Drugs adverse effects

    2 hours

  • Unstability in hemodynamic

    2 hours

Study Arms (4)

Metoprolol Per Oral

EXPERIMENTAL

50 mg Metoprolol

Drug: Metoprolol

Verapamil

EXPERIMENTAL

40 mg Verapamil Per Oral

Drug: Verapamil

Propranolol

EXPERIMENTAL

40 mg Propranolol Per Oral

Drug: Propranolol

Diltiazem

EXPERIMENTAL

60 mg Diltiazem Per Oral

Drug: Diltiazem

Interventions

Also known as: Inderal
Propranolol
Also known as: Metoral
Metoprolol Per Oral
Verapamil
Diltiazem

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age more than 18 years old
  • Stability in hemodynamic

You may not qualify if:

  • Systolic blood pressure less than 90 mm Hg
  • Altered mental status attributable to rapid ventricular response atrial fibrillation
  • Acute pulmonary edema attributable to rapid ventricular response atrial fibrillation
  • Chest pain attributable to rapid ventricular response atrial fibrillation
  • Allergy to Propranolol or Metoprolol or Verapamil or Diltiazem
  • History of asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rasoul-e-Akram Hospital

Tehran, Tehran Province, 14436151, Iran

Location

MeSH Terms

Interventions

PropranololMetoprololVerapamilDiltiazem

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsPhenethylaminesEthylaminesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2012

First Posted

August 1, 2012

Study Start

February 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations