Vitamin C in Atrial Fibrillation Ablation

Atrial Fibrillation Ablation Clinical Trial

— VitC-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03148236
• Other study ID #: HM20006786
• Status: Completed
• Phase: Phase 2
• Start date: September 18, 2017
• Est. completion date: March 13, 2018

Study information

• Verified date: March 2019
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 13, 2018
• Est. primary completion date: March 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation Ablation

Intervention

Drug:
• Vitamin C
200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W

Other:
• Placebo
50mL infused over 30 minutes

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

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