Atrial Fibrillation AblationPhase 2VitC-AFNCT03148236

Vitamin C in Atrial Fibrillation Ablation

A Phase 2 study testing Vitamin C in people with Atrial Fibrillation Ablation, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Atrial Fibrillation Ablation
What is being tested?: Vitamin C
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 18 Sep 2017to 13 Mar 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Virginia Commonwealth University
Richmond, Virginia, 23298

Other trials in United States

About this study

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

Conditions: Atrial Fibrillation Ablation
Being tested: Vitamin C, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vitamin CDrug
Also called Ascorbic Acid
200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W
PlaceboOther
Also called D5W
50mL infused over 30 minutes

Study groups in NCT03148236
Study group	Role	What they receive
Vitamin C	Active comparator	Not described Receives: Drug: Vitamin C
Placebo	Placebo comparator	Not described Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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)
Measured: baseline to 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Sep 201713 Mar 2018

First posted10 May 2017
Study start18 Sep 2017
Primary completion13 Mar 2018
Study completion13 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Atrial Fibrillation AblationStudies of the same condition, open and under way.
More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03148236
Sponsor's protocol ID: HM20006786
Acronym: VitC-AF
Status last verified: Mar 2019
First submitted: 1 May 2017
Last updated: 16 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Trankle CR, Puckett L, Swift-Scanlan T, DeWilde C, Priday A, Sculthorpe R, Ellenbogen KA, Fowler A, Koneru JN. Vitamin C Intravenous Treatment In the Setting of Atrial Fibrillation Ablation: Results From the Randomized, Double-Blinded, Placebo-Controlled CITRIS-AF Pilot Study. J Am Heart Assoc. 2020 Feb 4;9(3):e014213. doi: 10.1161/JAHA.119.014213. Epub 2020 Jan 30.
PubMed 32013700

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Atrial Fibrillation Patients Treated With Catheter Ablation
Atrial Fibrillation, Atrial Fibrillation Recurrent
Not yet recruiting
A Study to Predict Atrial Fibrillation (AF) Burden in Participants With PAF and PsAF Treated With the VARIPULSE™ PFA Catheter
Atrial Fibrillation
Not yet recruiting
Paroxysmal Atrial Fibrillation Repeat Ablation Strategies With Durably Isolated Pulmonary Veins
Ablation Techniques, Atrial Fibrillation (Paroxysmal)
Recruiting
Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
Atrial Fibrillation, Atrial Flutter
Not yet recruitingObservational study
Registry on Luma Vision's VERAFEYE System (ENLIgHT)
Atrial Fibrillation, Left Atrial Appendage Closure

All Atrial Fibrillation Ablation trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of the Safety and Efficacy of Intravenous Vitamin C in Patients Undergoing Atrial Fibrillation Ablation
ClinicalTrials.gov ID: NCT03148236
Acronym / sponsor ID: VitC-AF / HM20006786
Conditions: Atrial Fibrillation Ablation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Virginia Commonwealth UniversityUniversity, hospital or other
Study start: 18 Sep 2017 (actual)
Primary completion: 13 Mar 2018 (actual)
Study completion: 13 Mar 2018 (actual)
First posted: 10 May 2017 (actual)
Results: Posted 16 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Vitamin C	Active comparator	Drug: Vitamin C
Placebo	Placebo comparator	Other: Placebo

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vitamin CAlso: Ascorbic Acid200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W	Drug	Vitamin C
PlaceboAlso: D5W50mL infused over 30 minutes	Other	Placebo

Primary outcome

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

1 secondary outcome

Post Procedural Pain
Time frame: baseline to 24 hours

Results and safety

Results posted to the registry on 16 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vitamin C	10	10
Placebo	10	10

Primary outcome: Change in Creatinine Levels

Time frame: Baseline to 24 hours. Median (Inter-Quartile Range). Unit: mg/dL

Measure	Vitamin C n = 10	Placebo n = 10
Value	-0.1 (-0.2 to -0.1)	-0.1 (-0.2 to 0)

Primary outcome: Change in Plasma Levels of Ascorbic Acid

Time frame: baseline to 24 hours. Median (Inter-Quartile Range). Unit: micromolar

Measure	Vitamin C n = 10	Placebo n = 10
Value	267 (98 to 597)	-4 (-8 to -1)

Primary outcome: Change in hsCRP

Time frame: baseline to 24 hours. Median (Inter-Quartile Range). Unit: mg/L

Measure	Vitamin C n = 10	Placebo n = 10
Value	5.31 (4.48 to 7.92)	16.01 (9.40 to 29.29)

Primary outcome: Change in Interleukin (IL-6)

Time frame: baseline to 24 hours. Median (Inter-Quartile Range). Unit: pg/mL

Measure	Vitamin C n = 9	Placebo n = 10
Value	13.3 (6.6 to 29.4)	6.6 (2.6 to 12.1)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 90 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vitamin C	0 of 10 (0%)	1 of 10 (10%)	0 of 10
Placebo	0 of 10 (0%)	1 of 10 (10%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32013700Trankle CR, Puckett L, Swift-Scanlan T, DeWilde C, Priday A, Sculthorpe R, Ellenbogen KA, Fowler A, Koneru JN. Vitamin C Intravenous Treatment In the Setting of Atrial Fibrillation Ablation: Results From the Randomized, Double-Blinded, Placebo-Controlled CITRIS-AF Pilot Study. J Am Heart Assoc. 2020 Feb 4;9(3):e014213. doi: 10.1161/JAHA.119.014213. Epub 2020 Jan 30.
Individual participant dataSharing planned: No

Related trials for Atrial Fibrillation Ablation

RecruitingObservational study
Atrial Fibrillation Patients Treated With Catheter Ablation
Atrial Fibrillation, Atrial Fibrillation Recurrent
Not yet recruiting
A Study to Predict Atrial Fibrillation (AF) Burden in Participants With PAF and PsAF Treated With the VARIPULSE™ PFA Catheter
Atrial Fibrillation
Not yet recruiting
Paroxysmal Atrial Fibrillation Repeat Ablation Strategies With Durably Isolated Pulmonary Veins
Ablation Techniques, Atrial Fibrillation (Paroxysmal)
Recruiting
Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
Atrial Fibrillation, Atrial Flutter
Not yet recruitingObservational study
Registry on Luma Vision's VERAFEYE System (ENLIgHT)
Atrial Fibrillation, Left Atrial Appendage Closure

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jayanthe Koneru, MD principal investigator

Virginia Commonwealth University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vitamin C in people with Atrial Fibrillation Ablation, run by Virginia Commonwealth University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Creatinine Levels (time frame: Baseline to 24 hours). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03148236, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.