Vitamin C in Atrial Fibrillation Ablation (VitC-AF)

Pilot Study of the Safety and Efficacy of Intravenous Vitamin C in Patients Undergoing Atrial Fibrillation Ablation

Single-center, double-blinded, randomized, controlled safety and feasibility pilot study of high dose IV ascorbic acid (200mg/kg) over 24 hours, divided into four doses and administered every six hours with a 30 minute IV infusion time per dose, compared to matched placebo infusion

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation Ablation
• Intervention / Treatment: Drug: Vitamin C; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age >/= 21 years
2. Diagnosis of atrial fibrillation with plans for a catheter-based ablation procedure
3. Ability to provide informed consent and willingness to be included in the study

Exclusion Criteria:

1. Known allergy to Vitamin C
2. Inability to obtain informed consent
3. Diabetes mellitus either requiring the use of insulin therapy or not requiring the use of insulin therapy but which is uncontrolled, defined as a glycosylated hemoglobin of greater than or equal to 8%
4. Prior catheter-based ablation for atrial fibrillation
5. Pregnancy or breast feeding
6. Active renal calculus
7. Active acute or chronic infection (including HIV or hepatitis C)
8. Active or recent (within 5 years) malignancy
9. Autoimmune or autoinflammatory disease
10. Recent or active use of immunosuppressive medications
11. Non-English speaking
12. Ward of the state (inmate, other)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; 50mL infused over 30 minutes; Other Names: D5W
Active Comparator: Vitamin C	Drug: Vitamin C; 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W; Other Names: Ascorbic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Creatinine Levels	Change in Kidney Function	Baseline to 24 hours
Change in Plasma Levels of Ascorbic Acid	Change in plasma levels of ascorbic acid	baseline to 24 hours
Change in hsCRP	Biomarker of inflammation	baseline to 24 hours
Change in Interleukin (IL-6)	Biomarker of inflammation	baseline to 24 hours
Change in Von Willebrand Factor (vWF)	Biomarker of blood vessel damage	baseline to 24 hours
Change in Creatinine Levels	Change in kidney function	Baseline to 30 days
Change in Plasma Ascorbic Acid Level	Change in plasma ascorbic acid level	Baseline to 30 days
Change in hsCRP	Biomarker of inflammation	baseline to 30 days
Change in Interleukin (IL-6)	Biomarker of inflammation	baseline to 30 days
Change in Von Willebrand Factor (vWF)	Biomarker of blood vessel damage	baseline to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Procedural Pain	Sum of pain scores every six hours for the 24 hour period following ablation measured on a visual analog scale scored on a level from zero (no pain) to 10 (maximum pain)	baseline to 24 hours

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Jayanthe Koneru, MD, Virginia Commonwealth University

Publications and helpful links

General Publications

• Trankle CR, Puckett L, Swift-Scanlan T, DeWilde C, Priday A, Sculthorpe R, Ellenbogen KA, Fowler A, Koneru JN. 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. 2020 Feb 4;9(3):e014213. doi: 10.1161/JAHA.119.014213. Epub 2020 Jan 30.

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2017
• Primary Completion (Actual): March 13, 2018
• Study Completion (Actual): March 13, 2018

Study Registration Dates

• First Submitted: May 1, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: March 28, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: HM20006786

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No