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Upstream targeting for the prevention of atrial fibrillation: Targeting Risk Interventions and Metformin for Atrial Fibrillation (TRIM-AF)—rationale and study design

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2024年12月13日

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  • Sojin Y. Wass,
  • John Barnard,
  • Hyun Su Kim,
  • Han Sun,
  • William Telfer,
  • Taylor Schilling,
  • Benico Barzilai,
  • Dennis Bruemmer,
  • Leslie Cho,
  • Julie Huang,
  • Ayman Hussein,
  • Sangeeta R. Kashyap,
  • Luke Laffin,
  • Reena Mehra,
  • Chris Moravec,
  • Walid Saliba,
  • Prashanthan Sanders,
  • Steven Nissen,
  • Niraj Varma,
  • Jonathan Smith,
  • David Van Wagoner,
  • Mina K. Chung

摘要

Background

Despite advances in ablation and other therapies for AF, progression of atrial fibrillation (AF) remains a significant clinical problem, associated with worse prognosis and worse treatment outcomes. Upstream therapies targeting inflammatory or antifibrotic mechanisms have been disappointing in preventing AF progression, but more recently genetic and genomic studies in AF suggest novel cellular and metabolic stress targets, supporting prior studies of lifestyle and risk factor modification (LRFM) for AF. However, while obesity is a significant risk factor, weight loss and risk factor modification have not been successfully applied in a US population with AF. Metformin, a common drug that targets metabolic stress pathways, has demonstrated potential in reducing the burden of AF.

Methods

The Targeting Risk Interventions and Metformin for Atrial Fibrillation (TRIM-AF, NCT03603912) is a randomized clinical trial designed to examine reduction of AF burden and progression, targeting metabolic upstream therapies. This single center trial, at the Cleveland Clinic, is designed as a prospective randomized open-label blinded endpoint (PROBE) 2 × 2 factorial study of metformin extended release up to 750 mg twice daily and lifestyle and risk factor modification (LRFM) in patients with a cardiovascular implantable electronic device (CIED) that have had at least one ≥ 5-min episode of atrial fibrillation (AF) over the prior 3 months. Randomization is stratified by pacemaker vs. ICD and rhythm at enrollment (sinus rhythm/atrial paced vs. AF).

Conclusion

TRIM-AF trial aims to determine if metformin, lifestyle, and risk factor modification (LRFM) reduce AF burden and its progression and assess whether combined therapy outperforms individual treatments.

Trial registration

URL: https://clinicaltrials.gov/; Unique Identifier: NCT03603912.