Diltiazem vs. Metoprolol in the Acute Management of AF in Patients With HFrEF

NCT02938260 | Completed

• 1 other identifier: 16090607
• Study Type: observational
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

Atrial fibrillation (AF) is the most common arrhythmia, accounting for one third of all hospital admissions and 1% of all emergency department visits (ED). Approximately 65% of those presenting to the ED with AF are admitted. There are also numerous reasons for patients to get AF with rapid ventricular rate (AF RVR) during hospitalization. In the acute setting these patients are often treated with diltiazem, a non-dihydropyridine calcium channel blocker (ND CCB), or metoprolol, a beta blocker (BB). Non-dihydropyridine calcium channel blocker (diltiazem and verapamil) use is considered harmful and national guidelines recommend against use in patients with decompensated heart failure (HF). This recommendation is based on studies with long-term treatment. The purpose of this study is to assess the difference between metoprolol and diltiazem for the acute treatment of AF RVR in patients with HF with reduced ejection fraction (HFrEF).

Conditions

Atrial Fibrillation; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Successful rate control

  Successful rate control within 30 minutes from the first dose (HR \<100 bpm or a decrease by at least 20%).

  30 minutes

Secondary Outcomes (6)

• Successful rate control within 15 minutes

  15 minutes

• Successful rate control within 60 minutes

  60 minutes

• Bradycardia

  30 minutes

• Hypotension

  30 minutes

• Conversion

  30 minutes

Study Arms (2)

Diltiazem

Drug: Metoprolol vs Diltiazem

Metoprolol

Drug: Metoprolol vs Diltiazem

Interventions

Metoprolol vs Diltiazem DRUG

Diltiazem; Metoprolol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

To compare the achievement of a goal heart rate of \<100 bpm or a HR reduction of at least 20% in patients with HFrEF receiving intravenous diltiazem versus intravenous metoprolol for rate control of AF with RVR.

You may qualify if:

• Non-pregnant adults ≥18 years of age with AF RVR (HR \>120 bpm), which will be obtained from vital signs or electrocardiogram, in the emergency department, who have an EF \<40% from an echocardiogram within the previous 4 years, and are treated with IV push metoprolol or diltiazem as first line for rate control of AF with RVR. Patients can receive up to two IV push doses but cannot switch treatment medication between these two doses.

You may not qualify if:

• Patients with a SBP \<90 mmHg or decompensated heart failure (ie those presenting primarily with worsening of heart failure signs and symptoms, including dyspnea and lower extremity edema). Patients who are admitted multiple times within the time frame or have multiple episodes will be excluded except for the first episode within the first admission.

Sponsors & Collaborators

• RaeAnn Hirschy: lead

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PGY2-Critical Care

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 19, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: September 20, 2018

Record last verified: 2018-09