Oral Steroids Before Pulmonary Vein Isolation to Improve Outcomes

Atrial Fibrillation Clinical Trial

Official title:

Use of Oral Steroids Before Circumferential Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation to Improve Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01206452
• Other study ID #: 12153
• Status: Completed
• Phase: N/A
• First received: September 20, 2010
• Last updated: April 30, 2014
• Start date: September 2010
• Est. completion date: December 2013

Study information

• Verified date: April 2014
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

Description:

The purpose of this study is:

1. To assess the efficacy of oral prednisone in improving the outcomes of pulmonary vein isolation with radiofrequency ablation.

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Ablation plus prednisone
Ablation procedure plus 60mg of oral prednisone 2 days before procedure, 1 day before procedure, and day of procedure
• Ablation plus placebo
Ablation procedure plus placebo 2 days before procedure, 1 day before procedure, and day of procedure

Locations

Country	Name	City	State
United States	University Of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Dhanunjaya Lakkireddy, MD, FACC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. To assess the efficacy of oral prednisone in improving the outcomes of pulmonary vein isolation with radiofrequency ablation		day of ablation, 1day and 2 days before the procedure.	No
Secondary	Inflammatory cytokine (TNF-a, IL-1, IL-6, IL-8) response to radiofrequency ablation for atrial fibrillation with or without prior prednisone treatment.		day of ablation, 1day and 2 days before the procedure	No