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Clinical Trial
. 2025 May;25(3):411-418.
doi: 10.1007/s40256-024-00705-w. Epub 2024 Dec 26.

Effect of Digoxin vs Beta-Blockers on Left Atrial Strain for Heart Rate-Controlled Atrial Fibrillation: The DIGOBET-AF Randomized Clinical Trial

Nidhal Bouchahda  1 , Mouna Bader  2 , Aymen Najjar  3 , Fathia Mghaieth Zghal  2 , Ghada Sassi  3 , Mohamed Sami Mourali  2 , Mejdi Ben Messaoud  3
Affiliations
Clinical Trial

Effect of Digoxin vs Beta-Blockers on Left Atrial Strain for Heart Rate-Controlled Atrial Fibrillation: The DIGOBET-AF Randomized Clinical Trial

Nidhal Bouchahda et al. Am J Cardiovasc Drugs. 2025 May.

Abstract

BACKGROUND AND OBJECTIVE: Left atrial strain (LAS) has prognostic value in patients with atrial fibrillation (AF). Consequently, therapies that improve LAS may help reduce AF-related adverse cardiac events. We aimed to compare how digoxin and bisoprolol modulate LAS in patients with AF being treated with rate control.

Methods: This was a bicentric randomized controlled trial. Patients with AF, naïve to beta-blockers and digoxin, and scheduled for treatment with a rate control strategy were randomized to receive oral bisoprolol 5-10 mg daily or digoxin 0.25 mg daily. The primary aim was to compare the change in peak LAS before and after 30 days of treatment between the two groups.

Results: A total of 60 patients, equally distributed between the two groups, completed the trial. By day 30, there was no significant difference in global peak LAS between the groups. However, when analyzed separately, the two-chamber view showed a significantly higher peak LAS in the digoxin group than in the BB group (mean 7.5 ± standard deviation 3.2% vs. 5.9 ± 3.4%; p = 0.004). Similarly, the four-chamber view also showed a higher peak LAS in the digoxin group (7.2 ± 3.6% vs. 6.4 ± 3.8%; p = 0.047). Considering the entire LAS curve rather than solely the peak value, digoxin significantly increased all LAS curves. In the global and four-chamber view, the digoxin maximum effect occurred significantly earlier than the peak of the LAS curve (p < 0.001). This effect remained constant over the cardiac cycle in the two-chamber curve (p < 0.001).

Conclusion: Our findings suggest that, in patients with rate-controlled AF, digoxin positively modulates LAS when compared with bisoprolol.

Clinical trials registration number: NCT05540600, https://clinicaltrials.gov .

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Conflict of interest statement

Declarations. Funding: The authors declare that no funds, grants, or other support were received during the preparation of this manuscript. Conflict of interest: The authors have no relevant financial or non-financial interests to disclose. Author contributions: All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Nidhal Bouchahda, Mouna Bader, and Aymen Najjar. The first draft of the manuscript was written by Nidhal Bouchahda, and all authors commented on previous versions of the manuscript. Fathia Mghaieth Zghal, Ghada Sassi, Mohamed Sami Mourali, and Mejdi Ben Messaoud reviewed, improved, and approved the final manuscript. Ethics approval: This work was approved by the regional ethical committee (reference number TN2022-NAT-I NS-86). Consent to participate: Informed consent was obtained from all participants included in the study. Consent for publication: Not applicable. Availability of data and material: Data are available on reasonable request to the corresponding author. Code availability: The R code is available on reasonable request to the corresponding author.

References

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