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
About this trial
This is an interventional treatment trial for Atrial Fibrillation Ablation
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)
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
NCT ID
NCT03148236
First Posted
May 1, 2017
Last Updated
March 28, 2019
Sponsor
Virginia Commonwealth University
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
Learn more about this trial
Vitamin C in Atrial Fibrillation Ablation
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