Atrial FibrillationPhase 4NCT01206452
Oral Steroids Before Pulmonary Vein Isolation to Improve Outcomes
A Phase 4 study testing Prednisone and Ablation Procedure in people with Atrial Fibrillation, run by Dhanunjaya Lakkireddy, MD, FACC at 1 site in United States.
Trial summary
The primary purpose of this study is to assess the efficacy of oral prednisone in improving the outcomes of pulmonary vein isolation with radiofrequency ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Prednisone and Ablation Procedure
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Dec 2013
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent;
- Scheduled for radiofrequency ablation procedure for treatment of atrial fibrillation
Who cannot join
- History of heart failure (right or left or biventricular) or cardiomyopathy.
- Immunosuppressive disorders and systemic fungal infection
- Concurrent use of corticosteroids in one week prior recruitment.
- Allergy or prednisone or its components.
- Other medical conditions were use of corticosteroids is not recommended or contraindicated.
- Patients with chronic and permanent atrial fibrillation.
- Patients with established diagnosis of rheumatological and immunological disorders.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Use of Oral Steroids Before Circumferential Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation to Improve Outcomes
The primary purpose of this study is to assess the efficacy of oral prednisone in improving the outcomes of pulmonary vein isolation with radiofrequency ablation.
Read the detailed description
The purpose of this study is:
- To assess the efficacy of oral prednisone in improving the outcomes of pulmonary vein isolation with radiofrequency ablation.
- To measure the inflammatory cytokine (TNF-α, IL-1, IL-6, IL-8) response to radiofrequency ablation for atrial fibrillation with or without prior prednisone treatment.
- Conditions
- Atrial Fibrillation
- Being tested
- Prednisone, Placebo, Ablation Procedure
- Keywords
- Atrial Fibrillation; Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure
PlaceboOther
60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure
Ablation ProcedureProcedure or surgery
Atrial Fibrillation (AF) ablation
| Study group | Role | What they receive |
|---|---|---|
| Ablation plus prednisone | Experimental | Participants undergo ablation procedure and receive predinisone at protocol determined times. Receives: Drug: Prednisone; Procedure: Ablation Procedure |
| Ablation plus placebo | Placebo comparator | Participants undergo ablation procedure and receive placebo at protocol determined times. Receives: Other: Placebo; Procedure: Ablation Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Atrial Fibrillation Recurrence From 6 Months up to 12 Months
Number of AF recurrences between the two study groups as assessed by 1-month event monitor placed at 6 and 12 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence.
Measured: From 6 months up to 12 months post-procedure
Secondary outcomes (4)
Number of Participants With Atrial Fibrillation Recurrence From 0 Months up to 3 Months
Number of AF recurrences between the two study groups as assessed by inpatient telemetry in the immediate post-procedure period until discharge and 1-month event monitor placed at 3 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence.
Measured: From 0 months up to 3 months post procedure
Number of Participants With Atrial Fibrillation Recurrence From 3 Months up to 6 Months
Number of AF recurrences between the two study groups as assessed by 1-month event monitor placed at 3 and 6 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence.
Measured: From 3 months up to 6 months post-procedure
Inflammatory Cytokine Response to Ablation Procedure
Measure inflammatory marker levels, including IL-1, IL-6, IL-8, and TNF-α, immediately post-ablation in keeping with prior studies on the anti-inflammatory effects of steroids following cardiac surgery.
Measured: Immediately Post-Ablation Procedure
Inflammatory Cytokine Response to Ablation Procedure
Measure inflammatory marker levels, including IL-1, IL-6, IL-8, and TNF-α, 24 hours post-ablation to assess interval response to steroid administration.
Measured: 24 Hours after Ablation Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2013
- Study completionDec 2013
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.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dhanunjaya Lakkireddy, MD, FACC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center
- Investigators
- Dhanunjaya Lakkireddy, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206452
- Sponsor's protocol ID
- 12153
- Status last verified
- Apr 2017
- First submitted
- 20 Sep 2010
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Oral Steroids Before Circumferential Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation to Improve Outcomes
- ClinicalTrials.gov ID
- NCT01206452
- Acronym / sponsor ID
- 12153
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation; Ablation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dhanunjaya Lakkireddy, MD, FACCUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Sep 2010 (estimated)
- Results
- Posted 17 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to assess the efficacy of oral prednisone in improving the outcomes of pulmonary vein isolation with radiofrequency ablation.
Detailed description
The purpose of this study is:
- To assess the efficacy of oral prednisone in improving the outcomes of pulmonary vein isolation with radiofrequency ablation.
- To measure the inflammatory cytokine (TNF-α, IL-1, IL-6, IL-8) response to radiofrequency ablation for atrial fibrillation with or without prior prednisone treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ablation plus prednisone | Experimental | Drug: Prednisone, Procedure: Ablation ProcedureParticipants undergo ablation procedure and receive predinisone at protocol determined times. |
| Ablation plus placebo | Placebo comparator | Other: Placebo, Procedure: Ablation ProcedureParticipants undergo ablation procedure and receive placebo at protocol determined times. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to provide written informed consent;
- Scheduled for radiofrequency ablation procedure for treatment of atrial fibrillation
Key exclusion criteria (7 listed)
- History of heart failure (right or left or biventricular) or cardiomyopathy.
- Immunosuppressive disorders and systemic fungal infection
- Concurrent use of corticosteroids in one week prior recruitment.
- Allergy or prednisone or its components.
- Other medical conditions were use of corticosteroids is not recommended or contraindicated.
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 |
|---|---|---|
| Prednisone60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure | Drug | Ablation plus prednisone |
| Placebo60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure | Other | Ablation plus placebo |
| Ablation ProcedureAtrial Fibrillation (AF) ablation | Procedure or surgery | Ablation plus placebo, Ablation plus prednisone |
Primary outcome
Number of Participants With Atrial Fibrillation Recurrence From 6 Months up to 12 Months
Time frame: From 6 months up to 12 months post-procedure
Number of AF recurrences between the two study groups as assessed by 1-month event monitor placed at 6 and 12 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence.
4 secondary outcomes
Number of Participants With Atrial Fibrillation Recurrence From 0 Months up to 3 Months
Time frame: From 0 months up to 3 months post procedure
Number of Participants With Atrial Fibrillation Recurrence From 3 Months up to 6 Months
Time frame: From 3 months up to 6 months post-procedure
Inflammatory Cytokine Response to Ablation Procedure
Time frame: Immediately Post-Ablation Procedure
Inflammatory Cytokine Response to Ablation Procedure
Time frame: 24 Hours after Ablation Procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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Atrial Fibrillation (AF)
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.
Dhanunjaya Lakkireddy, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisone and Ablation Procedure in people with Atrial Fibrillation, run by Dhanunjaya Lakkireddy, MD, FACC 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 2 inclusion and 7 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 17 May 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 17 May 2017). 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?
Number of Participants With Atrial Fibrillation Recurrence From 6 Months up to 12 Months (time frame: From 6 months up to 12 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2017.