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

Diltiazem vs. Metoprolol in the Acute Management of Atrial Fibrillation in Patients With Heart Failure With Reduced Ejection Fraction

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02938260
Enrollment
48
Registered
2016-10-19
Start date
2016-10-31
Completion date
2017-03-31
Last updated
2018-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Heart Failure

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).

Detailed description

AF and HF are frequently seen in the hospital setting. AF affects over 2 million people in the United States, while HF affects over 5 million. These disease states have a significant morbidity and mortality impact with AF leading to a 4 fold increase in stroke and 2 fold increase in death, while 50% of patients with a new HF diagnosis will die within 5 years. These two disease states share several common risk factors including, age, hypertension, diabetes mellitus, and heart disease. Based on this relationship and the changes in myocardial structure, function, and conduction the two are also risk factors for one another. Of patients with HF, 61.5% of men and 73% of women develop AF. Of those with AF, 73% of men and 75.6% of women develop HF. Both the AF guidelines by the American Heart Association, American College of Cardiology, and Heart Rhythm Society and the HF guidelines by the American College of Cardiology Foundation and the American Heart Association recommend against the use of ND CCB in patients with HFrEF. The HF guidelines specify to avoid ND CCB in patients with reduced LVEF, but also mention avoiding most calcium channel blockers in general with the possible exception of amlodipine, due to known adverse effects and potential for harm. However, short term use of diltiazem for the acute control of RVR in patients with HFrEF has not been clearly evaluated. Three studies compare the use of BB and ND CCB in the acute treatment of AF RVR. These studies excluded those with severe (New York Heart Association Class IV) or decompensated HF, however, they did not comment on patients with compensated HFrEF. Most of these studies illustrate no difference, but the most recent study reported a success rate (heart rate (HR) \<100 bpm within 30 minutes) of 95.8% with intravenous (IV) diltiazem and 46.4% with IV metoprolol (p\<0.0001). When comparing use of long term and short term therapy in patients with HFrEF a different perspective emerges. Both BB and ND CCB have negative inotropic effects which can be harmful during an acute HF exacerbation and worsen symptoms. However, BB are routinely recommended for chronic use in HFrEF due to their added neurohormonal benefit, which over time delays HF progression and reduces mortality. In contrast, long term treatment with ND CCB in those with pulmonary congestion is associated with an increased cumulative rate of cardiac events (hazard ratio 1.41). The comparative short term benefit in patients is still unclear. In a small study, patients with AF RVR and severe HF, 97% treated with IV diltiazem had a HR reduction of \>20% and no evidence of HF exacerbation. A second study of patients in decompensated HF compared the use of IV metoprolol and diltiazem for control of AF RVR. Both agents were equally effective at controlling heart rate with no difference in safety endpoint or evidence of worsening heart failure. Neither of these studies specifically address compensated HFrEF. Current literature focuses on the risks associated with ND CCB and patients with HFrEF, but these effects are with long-term treatment. Studies in the acute setting often exclude those with severe or decompensated HFrEF. Therefore, a study focusing on metoprolol versus diltiazem for the acute control of AF RVR in patients with HFrEF could offer an insight into current clinical practice.

Interventions

DRUGMetoprolol vs Diltiazem

Sponsors

RaeAnn Hirschy
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Successful rate control30 minutesSuccessful rate control within 30 minutes from the first dose (HR \<100 bpm or a decrease by at least 20%).

Secondary

MeasureTime frameDescription
Successful rate control within 60 minutes60 minutesSuccessful rate control within 60 minutes
Bradycardia30 minutesHR \<60 bpm
Successful rate control within 15 minutes15 minutesSuccessful rate control within 15 minutes
Conversion30 minutesconversion to sinus rhythm
Worsening heart failure symptoms48hr/readmissionnew inotropic support, new pulmonary edema, or increased O2 requirement within 48 hr or readmission within 7 days of discharge
Hypotension30 minutesSBP \<90 mmHg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026