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Oral Steroids Before Pulmonary Vein Isolation to Improve Outcomes

This study is currently recruiting participants.
Verified January 2013 by University of Kansas
Sponsor:
Information provided by (Responsible Party):
Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01206452
First received: September 20, 2010
Last updated: January 8, 2013
Last verified: January 2013
History of Changes
  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:

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 2013
Estimated Primary Completion Date: September 2013 (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:

  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.
  Eligibility

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

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.
  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, 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            
Sponsors and Collaborators
Dhanunjaya Lakkireddy, MD, FACC
Investigators
Principal Investigator: Dhanunjaya Lakkireddy, MD University of Kansas
  More Information

No publications provided

Responsible Party: Dhanunjaya Lakkireddy, MD, FACC, Associate Professor of Medicine, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01206452     History of Changes
Other Study ID Numbers: 12153
Study First Received: September 20, 2010
Last Updated: January 8, 2013
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 16, 2013