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Completed

NCT Number: NCT03148236

Vitamin C in Atrial Fibrillation Ablation

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

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Key information

Conditions

Atrial Fibrillation Ablation

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vitamin C

Drug

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

Other names: Ascorbic Acid

Placebo

Other

50mL infused over 30 minutes

Other names: D5W

Primary outcomes

  1. Change in Creatinine Levels

    Time frame: Baseline to 24 hours

    Change in Kidney Function

  2. Change in Plasma Levels of Ascorbic Acid

    Time frame: baseline to 24 hours

    Change in plasma levels of ascorbic acid

  3. Change in hsCRP

    Time frame: baseline to 24 hours

    Biomarker of inflammation

  4. Change in Interleukin (IL-6)

    Time frame: baseline to 24 hours

    Biomarker of inflammation

  5. Change in Von Willebrand Factor (vWF)

    Time frame: baseline to 24 hours

    Biomarker of blood vessel damage

  6. Change in Creatinine Levels

    Time frame: Baseline to 30 days

    Change in kidney function

  7. Change in Plasma Ascorbic Acid Level

    Time frame: Baseline to 30 days

    Change in plasma ascorbic acid level

  8. Change in hsCRP

    Time frame: baseline to 30 days

    Biomarker of inflammation

  9. Change in Interleukin (IL-6)

    Time frame: baseline to 30 days

    Biomarker of inflammation

  10. Change in Von Willebrand Factor (vWF)

    Time frame: baseline to 30 days

    Biomarker of blood vessel damage

Secondary outcomes

  1. Post Procedural Pain

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

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

Acronym: VitC-AF

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 10, 2017
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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