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American Heart Association

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Final ID: 4169382

Randomized Controlled Trial of Metformin and Lifestyle/Risk Factor Modification for Upstream Prevention of Atrial Fibrillation Progression: The Targeting Risk Interventions and Metformin for Atrial Fibrillation (TRIM-AF) Trial

Abstract Body (Do not enter title and authors here): Background: Genomic data suggest atrial fibrillation (AF) susceptibility and progression may be associated with decreased transcriptional responses to metabolic stress, as might be exerted by obesity and aging. Metformin, nutrient deprivation and exercise are reported to have effects on AMP kinase, a master regulator of metabolic stress.

Hypothesis & Purpose: To determine if upstream targeting of metabolic pathways with metformin and/or weight loss and exercise can reduce AF burden and progression.

Population: Patients with pacemaker (PM) or implantable cardioverter-defibrillator (ICD) devices capable of recording daily AF burden, and at least 5 minutes of AF recorded over a 3-month period.

Methods: In a prospective, randomized, open label, blinded endpoint study, 150 patients were randomized in a 2x2 factorial design to Standard of Care (SOC, including written diet and exercise advice), metformin extended release up to 750 mg twice daily, lifestyle and risk factor modification (LRFM), or both metformin and LRFM. The primary endpoint was a composite of change from baseline to 1 year of average daily AF burden% after a 3-month blanking period and survival at 1 year.

Results: Among 149 eligible randomized patients (39 SOC, 37 Metformin, 35 LRFM, 38 LRFM+Metformin), mean age was 73.7±9.3 years, 58 (39%) were female, and median baseline AF burden was 4.3%. AF burden decreased in the SOC and LRFM arms over time, most significantly in the SOC arm. The primary composite endpoint was no different between SOC and LRFM and LRFM+Metformin arms, but tended to be worse (p=0.033) in the Metformin arm, which had a high rate of discontinuation due to side effects. LRFM+Metformin appeared synergistic compared to each intervention alone (interaction p value 0.011). AF symptom scores improved in the LRFM arms, but did not significantly change in the SOC or Metformin arms.

Conclusions: Metformin to reduce AF burden tended to be worse compared to SOC but was limited by side effects. The decrease in AF burden over time was not significantly different between SOC, which included written materials, and the more contact-intensive LRFM arms, though LRFM was associated with more improved AF symptom scores compared to SOC.
  • Chung, Mina  ( CLEVELAND CLINIC , Cleveland , Ohio , United States )
  • Cantlay, Catherine  ( Cleveland Clinic , Cleveland , Ohio , United States )
  • Crookshanks, Michael  ( Cleveland Clinic , Cleveland Heights , Ohio , United States )
  • Mchale, Megan  ( Cleveland Clinic , Cleveland Heights , Ohio , United States )
  • Lovano, Beth  ( Cleveland Clinic , Avon , Ohio , United States )
  • Castel, Laurie  ( Cleveland Clinic , Clevelalnd , Ohio , United States )
  • Park, Kevin  ( Cleveland Clinic , Cleveland Heights , Ohio , United States )
  • Foster, Parker  ( Cleveland Clinic , Cleveland Heights , Ohio , United States )
  • Guo, Lydia  ( Cleveland Clinic , Cleveland Heights , Ohio , United States )
  • Yang, Lucy  ( Cleveland Clinic , Cleveland Heights , Ohio , United States )
  • Sullivan, Erin  ( Cleveland Clinic , Cleveland Heights , Ohio , United States )
  • Wass, Sojin  ( Cleveland Clinic , Cleveland Heights , Ohio , United States )
  • Jin, Alison  ( Cleveland Clinic , Cleveland Heights , Ohio , United States )
  • Cantlay, Paul  ( Cleveland Clinic , Cleveland , Ohio , United States )
  • Varma, Niraj  ( Cleveland Clinic , Cleveland Heights , Ohio , United States )
  • Barzilai, Benico  ( CLEVELAND CLINIC , Cleveland , Ohio , United States )
  • Bruemmer, Dennis  ( Cleveland Clinic Foundation , Cleveland , Ohio , United States )
  • Cho, Leslie  ( CLEVELAND CLINIC FOUNDATION , Cleveland , Ohio , United States )
  • Huang, Julie  ( CLEVELAND CLINIC , Cleveland , Ohio , United States )
  • Hussein, Ayman  ( Cleveland Clinic , Cleveland , Ohio , United States )
  • Kashyap, Sangeeta  ( Cleveland Clinic , Cleveland Heights , Ohio , United States )
  • Xlaffinx, Xlukex  ( Cleveland Clinic Foundation , Cleveland , Ohio , United States )
  • Sun, Han  ( Cleveland Clinic , Cleveland , Ohio , United States )
  • Mehra, Reena  ( Cleveland Clinic , Cleveland , Ohio , United States )
  • Moravec, Christine  ( CLEVELAND CLINIC FOUNDATION , Cleveland , Ohio , United States )
  • Saliba, Walid  ( CLEVELAND CLINIC , Cleveland , Ohio , United States )
  • Wazni, Oussama  ( Cleveland Clinic , Cleveland , Ohio , United States )
  • Sanders, Prashanthan  ( University of Adelaide , Adelaide , South Australia , Australia )
  • Nissen, Steven  ( CLEVELAND CLINIC FOUNDATION , Cleveland , Ohio , United States )
  • Van Iterson, Erik  ( Cleveland Clinic , Cleveland , Ohio , United States )
  • Smith, Jonathan  ( CLEVELAND CLINIC FND , Cleveland , Ohio , United States )
  • Van Wagoner, David  ( CLEVELAND CLINIC , Chagrin Falls , Ohio , United States )
  • Barnard, John  ( CLEVELAND CLINIC , Cleveland , Ohio , United States )
  • Kim, Hyun Su  ( Cleveland Clinic , Cleveland , Ohio , United States )
  • Schilling, Taylor  ( Cleveland Clinic , Cleveland Heights , Ohio , United States )
  • Telfer, William  ( Cleveland Clinic , Cleveland , Ohio , United States )
  • Lissemore, Frances  ( Cleveland Clinic Foundation , Cleveland Heights , Ohio , United States )
  • Bibidakis, Dimitra  ( Cleveland Clinic , Cleveland Heights , Ohio , United States )
  • Lin, Cheryl  ( Cleveland Clinic , Cleveland , Ohio , United States )
  • Author Disclosures:
    Mina Chung: DO NOT have relevant financial relationships | Catherine Cantlay: DO NOT have relevant financial relationships | Michael Crookshanks: No Answer | Megan McHale: No Answer | Beth Lovano: No Answer | Laurie Castel: DO NOT have relevant financial relationships | Kevin Park: DO NOT have relevant financial relationships | Parker Foster: DO NOT have relevant financial relationships | Lydia Guo: DO NOT have relevant financial relationships | Lucy Yang: No Answer | Erin Sullivan: DO NOT have relevant financial relationships | Sojin Wass: No Answer | Alison Jin: DO NOT have relevant financial relationships | Paul Cantlay: No Answer | Niraj Varma: DO have relevant financial relationships ; Researcher:Impulse Dynamics:Active (exists now) | Benico Barzilai: DO NOT have relevant financial relationships | Dennis Bruemmer: DO have relevant financial relationships ; Advisor:Bayer:Active (exists now) ; Research Funding (PI or named investigator):Novartis:Active (exists now) ; Advisor:Esperion:Active (exists now) ; Advisor:Lilly:Active (exists now) | Leslie Cho: DO NOT have relevant financial relationships | Julie Huang: DO NOT have relevant financial relationships | Ayman Hussein: No Answer | Sangeeta Kashyap: DO NOT have relevant financial relationships | xLukex xLaffinx: DO have relevant financial relationships ; Consultant:Medtronic:Active (exists now) ; Consultant:Crispr Therapeutics:Active (exists now) ; Research Funding (PI or named investigator):Arrowhead Pharmaceuticals:Active (exists now) ; Consultant:Idorsia:Active (exists now) ; Consultant:Veradermics:Active (exists now) ; Advisor:Gordy Health:Past (completed) ; Advisor:LucidAct Health:Past (completed) ; Research Funding (PI or named investigator):Mineralys:Active (exists now) ; Research Funding (PI or named investigator):Astrazeneca:Active (exists now) ; Consultant:Lilly:Active (exists now) ; Speaker:Recor:Active (exists now) | Han Sun: DO NOT have relevant financial relationships | Reena Mehra: DO have relevant financial relationships ; Researcher:NIH:Active (exists now) ; Other (please indicate in the box next to the company name):AJRCCM, Associate Editor:Active (exists now) ; Other (please indicate in the box next to the company name):ABIM, Committee Member:Active (exists now) ; Royalties/Patent Beneficiary:Up to Date:Active (exists now) ; Researcher:Women in Alzheimer's Movement:Active (exists now) ; Consultant:Eli Lilly:Past (completed) | Christine Moravec: No Answer | Walid Saliba: DO have relevant financial relationships ; Advisor:boston scientific:Active (exists now) ; Advisor:siemens:Active (exists now) ; Advisor:biosense webster:Active (exists now) | Oussama Wazni: No Answer | Prashanthan Sanders: DO have relevant financial relationships ; Advisor:Medtronic:Active (exists now) ; Research Funding (PI or named investigator):Medtronic:Active (exists now) ; Research Funding (PI or named investigator):Abbott :Active (exists now) ; Research Funding (PI or named investigator):Boston Scientific:Active (exists now) ; Advisor:Pacemate:Active (exists now) ; Advisor:CathRx:Active (exists now) ; Advisor:Abbott :Active (exists now) ; Advisor:Boston Scientific:Active (exists now) | Steven Nissen: DO have relevant financial relationships ; Research Funding (PI or named investigator):Eli Lilly:Active (exists now) ; Research Funding (PI or named investigator):Arrowhead Pharmaceuticals:Active (exists now) ; Research Funding (PI or named investigator):Bristol Myers Squibb:Active (exists now) ; Research Funding (PI or named investigator):AstraZeneca:Active (exists now) ; Research Funding (PI or named investigator):Silence Therapeutics:Active (exists now) ; Research Funding (PI or named investigator):New Amsterdam Phrma.:Active (exists now) ; Research Funding (PI or named investigator):Novartis:Active (exists now) | Erik Van Iterson: DO NOT have relevant financial relationships | Jonathan Smith: DO NOT have relevant financial relationships | David Van Wagoner: DO have relevant financial relationships ; Research Funding (PI or named investigator):National Institutes of Health/NHLBI:Active (exists now) ; Research Funding (PI or named investigator):AHA:Past (completed) | John Barnard: No Answer | Hyun Su Kim: DO NOT have relevant financial relationships | Taylor Schilling: DO NOT have relevant financial relationships | William Telfer: No Answer | Frances Lissemore: DO NOT have relevant financial relationships | Dimitra Bibidakis: DO NOT have relevant financial relationships | Cheryl Lin: No Answer
Meeting Info:

Scientific Sessions 2024

2024

Chicago, Illinois

Session Info:

Revolutionizing AF Management: Cutting-Edge Approaches

Monday, 11/18/2024 , 09:45AM - 11:00AM

Late-Breaking Science

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