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Oral Steroids Before Pulmonary Vein Isolation to Improve Outcomes

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prednisone
Placebo
Ablation Procedure
Sponsored by
Dhanunjaya Lakkireddy, MD, FACC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation; Ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Able to provide written informed consent;
  2. Scheduled for radiofrequency ablation procedure for treatment of atrial fibrillation

Exclusion Criteria:

  1. History of heart failure (right or left or biventricular) or cardiomyopathy.
  2. Immunosuppressive disorders and systemic fungal infection
  3. Concurrent use of corticosteroids in one week prior recruitment.
  4. Allergy or prednisone or its components.
  5. Other medical conditions were use of corticosteroids is not recommended or contraindicated.
  6. Patients with chronic and permanent atrial fibrillation.
  7. Patients with established diagnosis of rheumatological and immunological disorders.

Sites / Locations

  • University Of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ablation plus prednisone

Ablation plus placebo

Arm Description

Participants undergo ablation procedure and receive predinisone at protocol determined times.

Participants undergo ablation procedure and receive placebo at protocol determined times.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
September 20, 2010
Last Updated
April 11, 2017
Sponsor
Dhanunjaya Lakkireddy, MD, FACC
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1. Study Identification

Unique Protocol Identification Number
NCT01206452
Brief Title
Oral Steroids Before Pulmonary Vein Isolation to Improve Outcomes
Official Title
Use of Oral Steroids Before Circumferential Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation to Improve Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dhanunjaya Lakkireddy, MD, FACC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation; Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ablation plus prednisone
Arm Type
Experimental
Arm Description
Participants undergo ablation procedure and receive predinisone at protocol determined times.
Arm Title
Ablation plus placebo
Arm Type
Placebo Comparator
Arm Description
Participants undergo ablation procedure and receive placebo at protocol determined times.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure
Intervention Type
Procedure
Intervention Name(s)
Ablation Procedure
Intervention Description
Atrial Fibrillation (AF) ablation
Primary Outcome Measure Information:
Title
Number of Participants With Atrial Fibrillation Recurrence From 6 Months up to 12 Months
Description
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.
Time Frame
From 6 months up to 12 months post-procedure
Secondary Outcome Measure Information:
Title
Number of Participants With Atrial Fibrillation Recurrence From 0 Months up to 3 Months
Description
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.
Time Frame
From 0 months up to 3 months post procedure
Title
Number of Participants With Atrial Fibrillation Recurrence From 3 Months up to 6 Months
Description
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.
Time Frame
From 3 months up to 6 months post-procedure
Title
Inflammatory Cytokine Response to Ablation Procedure
Description
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.
Time Frame
Immediately Post-Ablation Procedure
Title
Inflammatory Cytokine Response to Ablation Procedure
Description
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.
Time Frame
24 Hours after Ablation Procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to provide written informed consent; Scheduled for radiofrequency ablation procedure for treatment of atrial fibrillation Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dhanunjaya Lakkireddy, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Oral Steroids Before Pulmonary Vein Isolation to Improve Outcomes

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