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

NCT01914926 | Completed Phase 4 Results

• 1 other identifier: 09/01/VA02
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Acute atrial fibrillation is the most common sustained, clinically significant dysrhythmia encountered in the emergency department (ED) and the most common dysrhythmia treated by emergency physicians. Atrial flutter is less common than atrial fibrillation but its management in the ED is very similar, and the majority of patients with atrial flutter also have atrial fibrillation. Symptomatic relief and ventricular rate control are generally the primary therapeutic objectives in the ED management of acute atrial fibrillation and flutter (AFF). The need for swift, appropriate action by the emergency physician is highlighted by the fact that up to 18% of patients with AFF develop potentially life-threatening complications such as congestive heart failure, hypotension, ventricular ectopy, respiratory failure, angina and myocardial infarction. Both beta-blocking agents and calcium channel blockers are commonly used to treat AFF in the ED. Metoprolol is the most commonly used beta-blocker; and diltiazem is the most frequently used calcium channel antagonist.\[8\] Diltiazem was released by the FDA for treatment of AFF in 1992. Shreck et al. were the first to demonstrate both the efficacy of diltiazem in the ED management of AFF with rapid rate and its clear superiority over the previously most commonly used pharmacologic agent, digoxin. To date, only one prospective, randomized trial has compared the effectiveness of a calcium channel blocker (diltiazem) with a beta-blocker (metoprolol) for rate control of AFF in the ED. Despite the relatively small sample size (n=20 in each group) the authors concluded that both pharmacologic agents were similarly effective. In order to test this finding, the investigators conducted a prospective comparison of metoprolol and diltiazem for the management of patients presenting to the ED with AFF with rapid ventricular rate.

Conditions

Heart Rate and Rhythm Disorders

Keywords

metoprolol; diltiazem; heart rate

Outcome Measures

Primary Outcomes (1)

• Percent of Patients Reaching Target HR<100bpm Within 30 Minutes

  Percent of patient who reached a HR\<100bpm within 30 minutes from baseline.

  30 minutes

Study Arms (2)

Metoprolol Study Group

ACTIVE COMPARATOR

Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)

Drug: Metoprolol

Diltiazem Study Group

ACTIVE COMPARATOR

Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)

Drug: Diltiazem

Interventions

Metoprolol DRUG

Metoprolol Study Group

Diltiazem DRUG

Diltiazem Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients had to have a 12-lead electrocardiogram (ECG) showing atrial fibrillation or atrial flutter with a ventricular rate of greater than or equal to 120 beats per minute and a systolic blood pressure of greater than or equal to 90 mmHg.

You may not qualify if:

• Patients were excluded if they had any of the following:
• a systolic blood pressure \<90 mmHg, ventricular rate greater than or equal to 220 beats per minute,
• QRS \>0.100 seconds, 2nd or 3rd degree atrioventricular (AV) block,
• temperature \>38.0 ˚C,
• acute ST elevation myocardial infarction,
• known history of New York Heart Association Class IV heart failure or
• active wheezing with a history of bronchial asthma or COPD.
• In addition, patients were excluded if there was:
• prehospital administration of diltiazem or any other AV nodal blockading agent,
• a history of cocaine or methamphetamine use in the previous 24 hours prior to arrival,
• a history of allergic reaction to diltiazem or metoprolol,
• a history of sick sinus or pre-excitation syndromes,
• a history of anemia with hemoglobin \<11.0 g/dl,
• pregnancy or breastfeeding.

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Publications (13)

• Scott PA, Pancioli AM, Davis LA, Frederiksen SM, Eckman J. Prevalence of atrial fibrillation and antithrombotic prophylaxis in emergency department patients. Stroke. 2002 Nov;33(11):2664-9. doi: 10.1161/01.str.0000035260.70403.88.

  PMID: 12411658 BACKGROUND

• McDonald AJ, Pelletier AJ, Ellinor PT, Camargo CA Jr. Increasing US emergency department visit rates and subsequent hospital admissions for atrial fibrillation from 1993 to 2004. Ann Emerg Med. 2008 Jan;51(1):58-65. doi: 10.1016/j.annemergmed.2007.03.007. Epub 2007 Apr 27.

  PMID: 17466409 BACKGROUND

• Friberg J, Buch P, Scharling H, Gadsbphioll N, Jensen GB. Rising rates of hospital admissions for atrial fibrillation. Epidemiology. 2003 Nov;14(6):666-72. doi: 10.1097/01.ede.0000091649.26364.c0.

  PMID: 14569181 BACKGROUND

• Wattigney WA, Mensah GA, Croft JB. Increasing trends in hospitalization for atrial fibrillation in the United States, 1985 through 1999: implications for primary prevention. Circulation. 2003 Aug 12;108(6):711-6. doi: 10.1161/01.CIR.0000083722.42033.0A. Epub 2003 Jul 28.

  PMID: 12885749 BACKGROUND

• Stiell IG, Clement CM, Perry JJ, Vaillancourt C, Symington C, Dickinson G, Birnie D, Green MS. Association of the Ottawa Aggressive Protocol with rapid discharge of emergency department patients with recent-onset atrial fibrillation or flutter. CJEM. 2010 May;12(3):181-91. doi: 10.1017/s1481803500012227.

  PMID: 20522282 BACKGROUND

• Friedman HZ, Goldberg SF, Bonema JD, Cragg DR, Hauser AM. Acute complications associated with new-onset atrial fibrillation. Am J Cardiol. 1991 Feb 15;67(5):437-9. doi: 10.1016/0002-9149(91)90059-t. No abstract available.

  PMID: 1994672 BACKGROUND

• Chenoweth J, Diercks DB. Management of atrial fibrillation in the acute setting. Curr Opin Crit Care. 2012 Aug;18(4):333-40. doi: 10.1097/MCC.0b013e328354dc30.

  PMID: 22622515 BACKGROUND

• Demircan C, Cikriklar HI, Engindeniz Z, Cebicci H, Atar N, Guler V, Unlu EO, Ozdemir B. Comparison of the effectiveness of intravenous diltiazem and metoprolol in the management of rapid ventricular rate in atrial fibrillation. Emerg Med J. 2005 Jun;22(6):411-4. doi: 10.1136/emj.2003.012047.

  PMID: 15911947 BACKGROUND

• Kovacic JC, Moreno P, Nabel EG, Hachinski V, Fuster V. Cellular senescence, vascular disease, and aging: part 2 of a 2-part review: clinical vascular disease in the elderly. Circulation. 2011 May 3;123(17):1900-10. doi: 10.1161/CIRCULATIONAHA.110.009118. No abstract available.

  PMID: 21537006 BACKGROUND

• Stiell IG, Macle L; CCS Atrial Fibrillation Guidelines Committee. Canadian Cardiovascular Society atrial fibrillation guidelines 2010: management of recent-onset atrial fibrillation and flutter in the emergency department. Can J Cardiol. 2011 Jan-Feb;27(1):38-46. doi: 10.1016/j.cjca.2010.11.014.

  PMID: 21329861 BACKGROUND

• Rogenstein C, Kelly AM, Mason S, Schneider S, Lang E, Clement CM, Stiell IG. An international view of how recent-onset atrial fibrillation is treated in the emergency department. Acad Emerg Med. 2012 Nov;19(11):1255-60. doi: 10.1111/acem.12016.

  PMID: 23167856 BACKGROUND

• Maxwell CJ, Hogan DB, Campbell NR, Ebly EM. Nifedipine and mortality risk in the elderly: relevance of drug formulation, dose and duration. Pharmacoepidemiol Drug Saf. 2000 Jan;9(1):11-23. doi: 10.1002/(SICI)1099-1557(200001/02)9:13.0.CO;2-U.

  PMID: 19025798 BACKGROUND

• Jollis JG, Simpson RJ Jr, Chowdhury MK, Cascio WE, Crouse JR 3rd, Massing MW, Smith SC Jr. Calcium channel blockers and mortality in elderly patients with myocardial infarction. Arch Intern Med. 1999 Oct 25;159(19):2341-8. doi: 10.1001/archinte.159.19.2341.

  PMID: 10547174 BACKGROUND

MeSH Terms

Interventions

Metoprolol; Diltiazem

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Christian Fromm, MD; Director of Research
• Organization: Maimonides Medical Center

cfromm@maimonidesmed.org

718-283-6391

Study Officials

• John Marshall, MD

  Maimonides Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Manager

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: August 2, 2013
• Study Start: June 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: May 15, 2014
• Results First Posted: December 16, 2013

Record last verified: 2014-05

Locations

US (1)