Cleveland, Ohio 44195


Purpose:

The purpose of this study is to perform a prospective, randomized study for the reduction of atrial fibrillation (AF) burden and progression, targeting metabolic upstream therapies. The study aims to determine if metformin and/or lifestyle/risk factor modifications reduce AF burden and progression. A secondary aim will attempt to determine clinical, genomic, and biomarker predictors of AF progression that can be used to personalize upstream therapies. This is a prospective randomized open-label blinded endpoint (PROBE) 2x2 factorial study of metformin extended release up to 750 mg twice daily and lifestyle and risk factor modification (LRFM) in patients with implanted pacemakers or defibrillators with atrial leads and at least 1 ≥5 minute episode of AF over the prior 3 months.


Criteria:

TRIM-AF Cohorts Inclusion Criteria: 1. Permanent pacemaker or implantable cardioverter-defibrillator (ICD) (with or without cardiac resynchronization therapy (CRT) with an implanted atrial lead capable of providing AF diagnostics and remote monitoring. 2. Paroxysmal AF, or persistent AF with plans for conversion. 3. AF on cardiac implantable electrical device (CIED) over the past 3 months with at least 1 episode lasting ≥5 minutes. 4. If on an antiarrhythmic drug, then on a stable regimen for the past 3 months. Exclusion Criteria: 1. Permanent AF with no plans to convert to sinus rhythm. 2. If in persistent AF, current episode >12 months in duration (current long-standing persistent AF) 3. New York Heart Association (NYHA) Functional Class IV heart failure 4. Diagnosed with diabetes mellitus 5. On metformin or other pharmacologic therapy for diabetes mellitus. 6. Use of anti-retroviral protease inhibitors (e.g. ombitasvir, paritaprevir, ritonavir, dasabuvir) or topiramate. 7. Known sensitivity to metformin 8. Moderate renal disease (eGFR <45 ml/min/1.73 m2 or Cr >1.8) 9. Significant alcohol use (average >2 drinks/day) 10. Metabolic acidosis (serum bicarbonate <22 meq/L) or history of lactic acidosis 11. History of hepatic dysfunction - bilirubin >1.5x upper limits of normal, unless due to Gilbert's syndrome 12. Planned antiarrhythmic (class I or III) drug change, AF ablation/PVI procedure or cardiac surgery over the first 3 mos of the study 13. For patients on dofetilide, corrected QT interval (QTc) >460 ms if QRS duration is </=100 ms. If QRS duration is >100 ms, adjusted QTc >460 ms. Adjusted QTc = QTc - (QRS duration - 100 ms). 14. Women who are pregnant, breast-feeding or of child-bearing potential and not willing or able to use an acceptable form of contraception. 15. Participants considered by the investigator to be unsuitable for the study for any of the following reasons: Not agreeable for treatment with metformin or anticipated to have poor compliance on study drug treatment; inability to follow diet or exercise instructions; unwilling to attend study follow-up visits 16. Life expectancy less than 2 years due to concomitant disease. 17. Age <18 years old. TRIM - No AF Cohort Inclusion Criteria: 1. Permanent pacemaker or ICD (with or without CRT) with an implanted atrial lead capable of providing AF diagnostics and remote monitoring. 2. No AF on CIED over the past 6 months. 3. No history of AF. 4. Age >/=18 years old. Exclusion Criteria: 1. History of AF.


NCT ID:

NCT03603912


Primary Contact:

Mina K Chung, MD
Phone: 216-444-2290
Email: chungm@ccf.org


Backup Contact:

Email: varman@ccf.org
Niraj Varma, MD
Phone: 216 444-2142


Location Contact:

Cleveland, Ohio 44195
United States

Mina K Chung, MD
Phone: 216-444-2290
Email: chungm@ccf.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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