Oral Steroids Before Pulmonary Vein Isolation to Improve Outcomes - Full Text View

Sponsor:	University of Kansas
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT01206452

Purpose

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.

Condition	Intervention
Atrial Fibrillation	Drug: Ablation plus prednisone Drug: Ablation plus placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Use of Oral Steroids Before Circumferential Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation to Improve Outcomes

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: Prednisone

U.S. FDA Resources

Further study details as provided by University of Kansas:

Primary Outcome Measures:

1. To assess the efficacy of oral prednisone in improving the outcomes of pulmonary vein isolation with radiofrequency ablation [ Time Frame: day of ablation, 1day and 2 days before the procedure. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Inflammatory cytokine (TNF-α, IL-1, IL-6, IL-8) response to radiofrequency ablation for atrial fibrillation with or without prior prednisone treatment. [ Time Frame: day of ablation, 1day and 2 days before the procedure ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	September 2010
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ablation plus prednisone	Drug: Ablation plus prednisone Ablation procedure plus 60mg of oral prednisone 2 days before procedure, 1 day before procedure, and day of procedure
Placebo Comparator: Ablation plus placebo	Drug: Ablation plus placebo Ablation procedure plus placebo 2 days before procedure, 1 day before procedure, and day of procedure

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206452

Contacts

Contact: Donita Atkins, RN

913-588-9714

datkins@mac.md

Locations

United States, Arizona
Arizona Arrhythmia Research Center	Recruiting
Phoenix, Arizona, United States, 85016
Contact: Vijay Swarup, MD 480-414-6871 vswarup@azheartrhythm.com
Principal Investigator: Vijay Swarup, MD
United States, Kansas
University Of Kansas Medical Center	Recruiting
Kansas City, Kansas, United States, 66160
Contact: Donita Atkins, RN 913-588-9714 datkins@mac.md
Contact: Caroline Murray, CCRC 913-588-9679 cmurray@mac.md
Principal Investigator: Dhanunjaya Lakkireddy, MD
United States, Texas
Texas Cardiac Arrhythmia Research Foundation	Recruiting
Austin, Texas, United States, 78705
Contact: Andrea Natale, MD 512-458-9410 dscardinal@gmail.com
Principal Investigator: Andrea Natale, MD

Sponsors and Collaborators

University of Kansas

Investigators

Principal Investigator:

Dhanunjaya Lakkireddy, MD

University of Kansas

More Information

No publications provided

Responsible Party:	Dhanunjaya Lakkireddy, MD, University of Kansas
ClinicalTrials.gov Identifier:	NCT01206452 History of Changes
Other Study ID Numbers:	12153
Study First Received:	September 20, 2010
Last Updated:	June 20, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Kansas:

Atrial Fibrillation; Ablation

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Prednisone
Glucocorticoids
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2012