Vitamin C in Atrial Fibrillation Ablation

Phase 2

Completed

• Conditions: Atrial Fibrillation Ablation
• Interventions: Drug: Vitamin C; Other: Placebo

• Registration Number: NCT03148236
• Lead Sponsor: Virginia Commonwealth University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-01
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-10
• Study Start: 2017-09-18
• Primary Completion: 2018-03-13
• Study Completion: 2018-03-13
• Results First Submitted: 2019-02-22
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-28
• Last Update Submitted: 2019-03-28
• Results First Posted: 2019-04-16
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin C	Vitamin C	-
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Post Procedural Pain	baseline to 24 hours	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)

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States