Clinical trial NCT03148236: Vitamin C in Atrial Fibrillation Ablation
Official title: Pilot Study of the Safety and Efficacy of Intravenous Vitamin C in Patients Undergoing Atrial Fibrillation Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation Ablation
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

Primary outcomes:
measure: Change in Creatinine Levels
timeFrame: Baseline to 24 hours
measure: Change in Plasma Levels of Ascorbic Acid
timeFrame: baseline to 24 hours
measure: Change in hsCRP
timeFrame: baseline to 24 hours
measure: Change in Interleukin (IL-6)
timeFrame: baseline to 24 hours
measure: Change in Von Willebrand Factor (vWF)
timeFrame: baseline to 24 hours
measure: Change in Creatinine Levels
timeFrame: Baseline to 30 days
measure: Change in Plasma Ascorbic Acid Level
timeFrame: Baseline to 30 days
measure: Change in hsCRP
timeFrame: baseline to 30 days
measure: Change in Interleukin (IL-6)
timeFrame: baseline to 30 days
measure: Change in Von Willebrand Factor (vWF)
timeFrame: baseline to 30 days
Secondary outcomes:
measure: Post Procedural Pain
timeFrame: baseline to 24 hours
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Jayanthe Koneru, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.