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Oral Steroids Before Pulmonary Vein Isolation to Improve Outcomes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT01206452
First received: September 20, 2010
Last updated: April 11, 2017
Last verified: April 2017
  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 Phase
Atrial Fibrillation Drug: Prednisone Other: Placebo Procedure: Ablation Procedure Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


Further study details as provided by Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 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 [ Time Frame: From 3 months up to 6 months post-procedure ]
    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 [ Time Frame: Immediately Post-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 [ Time Frame: 24 Hours after 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.


Enrollment: 60
Study Start Date: September 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ablation plus prednisone
Participants undergo ablation procedure and receive predinisone at protocol determined times.
Drug: Prednisone
60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure
Procedure: Ablation Procedure
Atrial Fibrillation (AF) ablation
Placebo Comparator: Ablation plus placebo
Participants undergo ablation procedure and receive placebo at protocol determined times.
Other: Placebo
60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure
Procedure: Ablation Procedure
Atrial Fibrillation (AF) ablation

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Kansas
University Of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Dhanunjaya Lakkireddy, MD, FACC
Investigators
Principal Investigator: Dhanunjaya Lakkireddy, MD University of Kansas Medical Center
  More Information

Responsible Party: Dhanunjaya Lakkireddy, MD, FACC, Professor of Medicine, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01206452     History of Changes
Other Study ID Numbers: 12153
Study First Received: September 20, 2010
Results First Received: January 25, 2016
Last Updated: April 11, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center:
Atrial Fibrillation; Ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 18, 2017