Atrial Fibrillation Ablation
Conditions
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
Interventions
DRUGVitamin C
200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W
OTHERPlacebo
50mL infused over 30 minutes
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hsCRP | baseline to 24 hours | Biomarker of inflammation |
| Change in Creatinine Levels | Baseline to 24 hours | Change in Kidney Function |
| Change in Plasma Levels of Ascorbic Acid | baseline to 24 hours | Change in plasma levels of ascorbic acid |
| Change in Plasma Ascorbic Acid Level | Baseline to 30 days | Change in plasma ascorbic acid level |
| Change in Interleukin (IL-6) | baseline to 24 hours | Biomarker of inflammation |
| Change in Von Willebrand Factor (vWF) | baseline to 24 hours | Biomarker of blood vessel damage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vitamin C Vitamin C: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W | 10 |
| Placebo Placebo: 50mL infused over 30 minutes | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Total | Vitamin C | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 7 Participants | 5 Participants |
| Age, Continuous | 63 years | 60.5 years | 65 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 10 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 9 Participants | 10 Participants |
| Region of Enrollment United States | 20 participants | 10 participants | 10 participants |
| Sex: Female, Male Female | 7 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Male | 13 Participants | 6 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 1 / 10 | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Change in Creatinine Levels
Change in Kidney Function
Time frame: Baseline to 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vitamin C | Change in Creatinine Levels | -0.1 mg/dL |
| Placebo | Change in Creatinine Levels | -0.1 mg/dL |
Primary
Change in Creatinine Levels
Change in kidney function
Time frame: Baseline to 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vitamin C | Change in Creatinine Levels | 0 mg/dL |
| Placebo | Change in Creatinine Levels | 0.1 mg/dL |
Primary
Change in hsCRP
Biomarker of inflammation
Time frame: baseline to 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vitamin C | Change in hsCRP | 5.31 mg/L |
| Placebo | Change in hsCRP | 16.01 mg/L |
Primary
Change in hsCRP
Biomarker of inflammation
Time frame: baseline to 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vitamin C | Change in hsCRP | -0.30 mg/L |
| Placebo | Change in hsCRP | -0.64 mg/L |
Primary
Change in Interleukin (IL-6)
Biomarker of inflammation
Time frame: baseline to 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vitamin C | Change in Interleukin (IL-6) | 13.3 pg/mL |
| Placebo | Change in Interleukin (IL-6) | 6.6 pg/mL |
Primary
Change in Interleukin (IL-6)
Biomarker of inflammation
Time frame: baseline to 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vitamin C | Change in Interleukin (IL-6) | 0 pg/mL |
| Placebo | Change in Interleukin (IL-6) | 0.1 pg/mL |
Primary
Change in Plasma Ascorbic Acid Level
Change in plasma ascorbic acid level
Time frame: Baseline to 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vitamin C | Change in Plasma Ascorbic Acid Level | 3 micromolar |
| Placebo | Change in Plasma Ascorbic Acid Level | -5 micromolar |
Primary
Change in Plasma Levels of Ascorbic Acid
Change in plasma levels of ascorbic acid
Time frame: baseline to 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vitamin C | Change in Plasma Levels of Ascorbic Acid | 267 micromolar |
| Placebo | Change in Plasma Levels of Ascorbic Acid | -4 micromolar |
Primary
Change in Von Willebrand Factor (vWF)
Biomarker of blood vessel damage
Time frame: baseline to 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vitamin C | Change in Von Willebrand Factor (vWF) | 0.4 micrograms/mL |
| Placebo | Change in Von Willebrand Factor (vWF) | 0.4 micrograms/mL |
Primary
Change in Von Willebrand Factor (vWF)
Biomarker of blood vessel damage
Time frame: baseline to 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vitamin C | Change in Von Willebrand Factor (vWF) | -2.3 micrograms/mL |
| Placebo | Change in Von Willebrand Factor (vWF) | -3.8 micrograms/mL |
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)
Time frame: baseline to 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vitamin C | Post Procedural Pain | 4.5 score on a scale |
| Placebo | Post Procedural Pain | 0.3 score on a scale |