Research: TRANKLE and COLLEAGUES

Listed in Issue 278

Abstract

TRANKLE and COLLEAGUES,1 Division of Cardiology Pauley Heart Center Virginia Commonwealth University Richmond VA; 2 Johnson Center for Critical Care and Pulmonary Research Virginia Commonwealth University Richmond VA; 3 School of Nursing Virginia Commonwealth University Richmond VA; 4 Investigational Drug Service Virginia Commonwealth University Richmond VA; 5 Division of Pulmonary Disease and Critical Care Medicine Department of Internal Medicine Virginia Commonwealth University Richmond VA conducted a randomized, double-blinded, placebo-controlled trial to test the feasibility, safety, and preliminary effects on inflammatory biomarkers in the CITRIS-AF (Vitamin C Intravenous Treatment In the Setting of Atrial Fibrillation Ablation) pilot study.

Background

Catheter ablation is an effective treatment for atrial fibrillation (AF), but high levels of post-procedure inflammation predict adverse clinical events. Ascorbic acid (AA) has shown promise in reducing inflammation but is untested in this population. We sought to test the feasibility, safety, and preliminary effects on inflammatory biomarkers in the CITRIS-AF (Vitamin C Intravenous Treatment In the Setting of Atrial Fibrillation Ablation) pilot study.

Methodology

Patients scheduled to undergo AF ablation (N=20) were randomized 1:1 to double-blinded treatment with Ascorbic acid (AA) (200 mg/kg divided over 24 hours) or placebo. C-reactive protein and interleukin-6 levels were obtained before the first infusion and repeated at 24 hours and 30 days. Pain levels within 24 hours and early recurrence of AF within 90 days were recorded. Median and interquartile range were aged 63 (56-70) years, 13 (65%) men, and 18 (90%) white. Baseline data were similar between the 2 groups except ejection fraction. Baseline C-reactive protein levels were 2.56 (1.47-5.87) mg/L and similar between groups (P=0.48).

Results

Change in C-reactive protein from baseline to 24 hours was +10.79 (+6.56-23.19) mg/L in the placebo group and +3.01 (+0.40-5.43) mg/L in the AA group (P=0.02). Conversely, change in interleukin-6 was numerically higher in the AA group, though not statistically significant (P=0.32). One patient in each arm developed pericarditis; no adverse events related to the infusions were seen. There were no significant differences between aggregated post-procedure pain levels within 24 hours or early recurrence of AF (both P>0.05).

Conclusion

High-dose Ascorbic acid – AA is safe and well tolerated at the time of Atrial Fibrillation (AF) ablation and may be associated with a blunted rise in C-reactive protein, although consistent findings were not seen in interleukin-6 levels. Further studies are needed to validate these findings and explore the potential benefit in improving clinically relevant outcomes. Clinical Trial Registration URL: http://www.clinicaltrials.gov . Unique identifier: NCT03148236.

References

Cory R Trankle  1 , Laura Puckett  2 , Theresa Swift-Scanlan  3 , Christine DeWilde  2 , Anna Priday  2 , Robin Sculthorpe  4 , Kenneth A Ellenbogen  1 , Alpha Fowler  2   5 , Jayanthi N Koneru  1. Vitamin C Intravenous Treatment In the Setting of Atrial Fibrillation Ablation: Results From the Randomized, Double-Blinded, Placebo-Controlled CITRIS-AF Pilot Study J Am Heart Assoc; 9(3):e014213. doi: 10.1161/JAHA.119.014213. https://www.ahajournals.org/doi/10.1161/JAHA.119.014213 Epub Jan 30 2020 . Feb 4 2020.

ICAN Skyscraper

Scientific and Medical Network 2

Cycle Around the World for Charity 2023

Climb Mount Kilimanjaro Charity 2023

top of the page