Phase 2
Completed N=20
Vitamin C in Atrial Fibrillation Ablation
Atrial Fibrillation Ablation
Source: ClinicalTrials.gov NCT03148236 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Change in Creatinine Levels — -0.1; -0.1 mg/dL
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Creatinine Levels |
0; 0.1 | — |
| PRIMARY Change in Plasma Levels of Ascorbic Acid |
267; -4 | — |
| PRIMARY Change in hsCRP |
-0.30; -0.64 | — |
| PRIMARY Change in Interleukin (IL-6) |
0; 0.1 | — |
| PRIMARY Change in Von Willebrand Factor (vWF) |
-2.3; -3.8 | — |
| PRIMARY Change in Creatinine Levels |
0; 0.1 | — |
| PRIMARY Change in Plasma Ascorbic Acid Level |
3; -5 | — |
| PRIMARY Change in hsCRP |
-0.30; -0.64 | — |
| PRIMARY Change in Interleukin (IL-6) |
0; 0.1 | — |
| PRIMARY Change in Von Willebrand Factor (vWF) |
-2.3; -3.8 | — |
| SECONDARY Post Procedural Pain |
4.5; 0.3 | — |
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)
Data sourced from ClinicalTrials.gov (NCT03148236). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.