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Vitamin C in Atrial Fibrillation Ablation (VitC-AF)

Primary Purpose

Atrial Fibrillation Ablation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vitamin C
Placebo
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation Ablation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitamin C

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in Creatinine Levels
Change in Kidney Function
Change in Plasma Levels of Ascorbic Acid
Change in plasma levels of ascorbic acid
Change in hsCRP
Biomarker of inflammation
Change in Interleukin (IL-6)
Biomarker of inflammation
Change in Von Willebrand Factor (vWF)
Biomarker of blood vessel damage
Change in Creatinine Levels
Change in kidney function
Change in Plasma Ascorbic Acid Level
Change in plasma ascorbic acid level
Change in hsCRP
Biomarker of inflammation
Change in Interleukin (IL-6)
Biomarker of inflammation
Change in Von Willebrand Factor (vWF)
Biomarker of blood vessel damage

Secondary Outcome Measures

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)

Full Information

First Posted
May 1, 2017
Last Updated
March 28, 2019
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT03148236
Brief Title
Vitamin C in Atrial Fibrillation Ablation
Acronym
VitC-AF
Official Title
Pilot Study of the Safety and Efficacy of Intravenous Vitamin C in Patients Undergoing Atrial Fibrillation Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 18, 2017 (Actual)
Primary Completion Date
March 13, 2018 (Actual)
Study Completion Date
March 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin C
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Vitamin C
Other Intervention Name(s)
Ascorbic Acid
Intervention Description
200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
D5W
Intervention Description
50mL infused over 30 minutes
Primary Outcome Measure Information:
Title
Change in Creatinine Levels
Description
Change in Kidney Function
Time Frame
Baseline to 24 hours
Title
Change in Plasma Levels of Ascorbic Acid
Description
Change in plasma levels of ascorbic acid
Time Frame
baseline to 24 hours
Title
Change in hsCRP
Description
Biomarker of inflammation
Time Frame
baseline to 24 hours
Title
Change in Interleukin (IL-6)
Description
Biomarker of inflammation
Time Frame
baseline to 24 hours
Title
Change in Von Willebrand Factor (vWF)
Description
Biomarker of blood vessel damage
Time Frame
baseline to 24 hours
Title
Change in Creatinine Levels
Description
Change in kidney function
Time Frame
Baseline to 30 days
Title
Change in Plasma Ascorbic Acid Level
Description
Change in plasma ascorbic acid level
Time Frame
Baseline to 30 days
Title
Change in hsCRP
Description
Biomarker of inflammation
Time Frame
baseline to 30 days
Title
Change in Interleukin (IL-6)
Description
Biomarker of inflammation
Time Frame
baseline to 30 days
Title
Change in Von Willebrand Factor (vWF)
Description
Biomarker of blood vessel damage
Time Frame
baseline to 30 days
Secondary Outcome Measure Information:
Title
Post Procedural Pain
Description
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)
Time Frame
baseline to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >/= 21 years Diagnosis of atrial fibrillation with plans for a catheter-based ablation procedure Ability to provide informed consent and willingness to be included in the study Exclusion Criteria: Known allergy to Vitamin C Inability to obtain informed consent 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% Prior catheter-based ablation for atrial fibrillation Pregnancy or breast feeding Active renal calculus Active acute or chronic infection (including HIV or hepatitis C) Active or recent (within 5 years) malignancy Autoimmune or autoinflammatory disease Recent or active use of immunosuppressive medications Non-English speaking Ward of the state (inmate, other)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayanthe Koneru, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32013700
Citation
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.
Results Reference
derived

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Vitamin C in Atrial Fibrillation Ablation

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