What is the clinical evidence from this study?

Study design: RCT. Population: Heart failure with arrhythmia (n=86). Intervention: Amiodarone vs. Regular medication (isosorbide mononitrate, aspirin, digoxin, furosemide). Primary outcome: Clinical effectiveness rate (p=0.047).

January 1, 2022Open Access

Efficacy of Amiodarone on the Heart Failure Patients with Arrhythmia

Key Result

Amiodarone significantly improved the clinical effectiveness rate to 93.02% compared to 72.09% with regular medication alone in heart failure patients with arrhythmia.

Study Design

Type

RCT (n=86)

Randomization

Sequence of admission

Multicenter

Structured PICO

Does amiodarone improve clinical efficacy and hemodynamic parameters in heart failure patients with arrhythmia?

Population

86 heart failure patients with arrhythmia were randomized to receive regular medication with or without amiodarone to evaluate clinical efficacy and hemodynamic parameters.

Intervention

Amiodarone (amiodarone hydrochloride injection 150 mg + 5% glucose 20 ml via IV infusion, followed by an additional 150 mg, then oral amiodarone tablet 300 mg once per day) added to regular medication.

Comparator

Regular medication alone (isosorbide mononitrate sustained release tablets 40 mg once daily, aspirin enteric-coated tablets 100 mg once daily, digoxin tablets 0.125 mg once daily, and furosemide tablets 40 mg once daily).

Outcome

Clinical efficacy (effectiveness rate based on symptoms, cardiac rhythm, and heart function grade) and hemodynamic parameters (mean arterial pressure, cardiac output, cardiac index, ejection fraction, fractional shortening, and E/A ratio).composite

Amiodarone added to standard therapy significantly improved clinical effectiveness and hemodynamic parameters in heart failure patients with arrhythmia without increasing adverse reactions.

Main Result

Absolute Event Rate: 93.02% vs 72.09%

p-value: p=0.047

Limitations

Small sample size
Single-center study
Quasi-randomization based on sequence of admission
Lack of blinding

Abstract

To investigate the efficacy of amiodarone on the heart failure patients with arrhythmia is the objective of the study. Between April 2018 and April 2020, 86 heart failure patients with arrhythmia who were admitted to the hospital for treatment were enrolled into the study and numbered, and according to the sequence of admission, they were randomized into the control group and observation group, with 43 patients in each group. Patients in two groups received the regular medication, while those in the observation group additionally took amiodarone. We measured the hemodynamic parameters of patients in two groups before and after treatment, including the mean arterial pressure, cardiac output, cardiac index, ejection fraction, fractional shortening and maximal flow velocity in early diastolic stage/maximal flow velocity in advanced diastolic stage, evaluated the efficacy and recorded the incidence rate of adverse reactions. Following the treatment, the effectiveness rate of patients in the observation group was significantly higher than that in the control group (c2=3.927, p0.05). Amiodarone in treatment of heart failure patients with arrhythmia can improve the heart function and efficacy, and thus it is safe and efficient in clinical practice.

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