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Comparison of Diltiazem and Metoprolol in the Management of Acute Atrial Fibrillation or Atrial Flutter (DiME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01914926
Recruitment Status : Completed
First Posted : August 2, 2013
Results First Posted : December 16, 2013
Last Update Posted : May 15, 2014
Sponsor:
Information provided by (Responsible Party):
Antonios Likourezos, Maimonides Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Heart Rate and Rhythm Disorders
Interventions Drug: Metoprolol
Drug: Diltiazem
Enrollment 54
Recruitment Details Recruitment of patients was from June 2009 to November 2010
Pre-assignment Details No significant events
Arm/Group Title Metoprolol Study Group Diltiazem Study Group
Hide Arm/Group Description Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg) Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
Period Title: Overall Study
Started 29 25
Completed 28 24
Not Completed 1 1
Reason Not Completed
Adverse Event             1             0
uncooperative, agitated and removed             0             1
Arm/Group Title Metoprolol Study Group Diltiazem Study Group Total
Hide Arm/Group Description Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg) Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg) Total of all reporting groups
Overall Number of Baseline Participants 29 25 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 25 participants 54 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
  37.9%
13
  52.0%
24
  44.4%
>=65 years
18
  62.1%
12
  48.0%
30
  55.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 25 participants 54 participants
68.95  (14.94) 65.85  (13.22) 67.52  (14.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 25 participants 54 participants
Female
17
  58.6%
15
  60.0%
32
  59.3%
Male
12
  41.4%
10
  40.0%
22
  40.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants 25 participants 54 participants
29 25 54
1.Primary Outcome
Title Percent of Patients Reaching Target HR<100bpm Within 30 Minutes
Hide Description Percent of patient who reached a HR<100bpm within 30 minutes from baseline.
Time Frame 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metoprolol Study Group Diltiazem Study Group
Hide Arm/Group Description:
Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)
Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
Overall Number of Participants Analyzed 28 24
Measure Type: Number
Unit of Measure: percentage of participants
46.4 95.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Metoprolol Study Group, Diltiazem Study Group
Comments We estimated a sample size of 200 patients assigned in a 1:1 ratio to receive diltiazem and metoprolol would achieve 80% power to detect non-inferiority using a one-sided two sample t-test. The margin of equivalence is -10.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Chi-Square test
Statistical Test of Hypothesis P-Value .0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metoprolol Study Group Diltiazem Study Group
Hide Arm/Group Description Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg) Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
All-Cause Mortality
Metoprolol Study Group Diltiazem Study Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Metoprolol Study Group Diltiazem Study Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/25 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Metoprolol Study Group Diltiazem Study Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/25 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christian Fromm, MD; Director of Research
Organization: Maimonides Medical Center
Phone: 718-283-6391
EMail: cfromm@maimonidesmed.org
Publications:
Layout table for additonal information
Responsible Party: Antonios Likourezos, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT01914926    
Other Study ID Numbers: 09/01/VA02
First Submitted: July 11, 2013
First Posted: August 2, 2013
Results First Submitted: October 23, 2013
Results First Posted: December 16, 2013
Last Update Posted: May 15, 2014