Early Versus Late DC-cardioversion of Persistent Atrial Fibrillation. Effect on Atrial Remodeling,Inflammatory and Neurohumoral Markers and Recurrence of Atrial Fibrillation

This study is currently recruiting participants.
Verified May 2012 by Odense University Hospital
Sponsor:
Information provided by (Responsible Party):
Armin Osmanagic, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01593150
First received: May 2, 2012
Last updated: May 9, 2012
Last verified: May 2012
  Purpose

Atrial fibrillation (AF) is the most common arrhythmia present in 1% of population under 60 years of age and reaching up to 15% at 80 years. AF is associated with reduced quality of life, increased morbidity, mortality and health economic costs.

Presentation of AF differs substantially among patients ranging from self-limiting short episodes (paroxysmal AF), longstanding episodes (persistent AF) where direct current (DC) cardioversion is needed, to chronic atrial fibrillation. Treatment of AF is individually tailored in accordance to symptoms, type of AF and thromboembolic risk. The standard treatment of symptomatic persistent AF is DC-cardioversion preceded by anticoagulant treatment with Warfarin. According to guidelines DC-cardioversion can be performed when anticoagulation treatment has been in therapeutic range for at least 4 weeks. However introduction of Pradaxa (Dabigatran) has enabled an earlier DC cardioversion, reducing time to cardioversion to a 3 week period. During anticoagulation treatment persistence of AF contributes to left atrial remodeling and increases in inflammatory and neurohumoral biomarkers. The prolonged duration of AF and the remodeling of the left atrium increase the risk of AF recurrence after DC-cardioversion.

Early cardioversion of patients with persistent AF is possible if preceded by transesophageal echocardiography (TEE). The TEE guided DC- cardioversion, as demonstrated in the ACUTE study, is a safe and efficient alternative to conventional treatment. This treatment regime is not routinely used in clinical practice.

The aim of this study is to compare early DC-cardioversion (within 72 hours) to conventional treatment (Pradaxa prior to DC-cardioversion). 140 patients with persistent AF will be randomized to early cardioversion preceded by TEE in accordance with guidelines or conventional treatment with Pradaxa for 4 weeks prior to DC-cardioversion.

The investigators will determine the outcome in the two groups regarding:

  • Left atrial function and size assessed by left atrial strain, left atrial ejection fraction and left atrial volume.
  • Inflammatory and neurohumoral biomarkers including ANP, BNP,IL6 and CRP.
  • Time to recurrence of AF (AF documented by ECG or Holter monitoring)

Comprehensive transthoracic echocardiography, 12 lead ECG, biomarkers and Holter monitoring will be performed at the time of randomization, 4 weeks, 3 month and 6 month post DC-cardioversion. Furthermore all patients will be followed for symptomatic AF recurrence for a period of one year. AF recurrence will be documented by 12 lead ECG.


Condition Intervention
Atrial Fibrillation
Drug: Pradaxa
Procedure: TEE
Other: Compare TEE guided cardioversion to Dabigatran + DC cardioversion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Versus Late DC-cardioversion of Persistent Atrial Fibrillation. Effect on Atrial Remodeling,Inflammatory and Neurohumoral Markers and Recurrence of Atrial Fibrillation.

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Difference in function and size of the left atrium, prior to and post cardioversion comparing early cardioversion to conventional treatment group. The data for comparison will be acquired echocardiographically [ Time Frame: Baseline compared to 12 months post DC cardioversion ] [ Designated as safety issue: No ]
    Difference in function and size of the left atrium, prior to and post cardioversion comparing early cardioversion to conventional treatment group. The data for comparison will be acquired echocardiographically

  • Difference in time to recurrence of, ECG or Holter verified AF, when comparing early cardioversion to conventional treatment. [ Time Frame: Baseline compared to 12 months post DC cardioversion ] [ Designated as safety issue: No ]
    Difference in time to recurrence of, ECG or Holter verified AF, when comparing early cardioversion to conventional treatment.

  • Difference in levels of inflammatory (IL-6 & CRP) and neurohumoral markers (ANP & BNP) prior to and post cardioversion, when comparing early cardioversion to conventional treatment group. [ Time Frame: Baseline compared to 12 months post DC cardioversion ] [ Designated as safety issue: No ]
    Difference in levels of inflammatory (IL-6 & CRP) and neurohumoral markers (ANP & BNP) prior to and post cardioversion, when comparing early cardioversion to conventional treatment group.


Secondary Outcome Measures:
  • Difference in correlation between left atrial size and function and neurohumoral or inflammatory biomarker levels pre/post cardioversion, when comparing early cardioversion to conventional treatment group. [ Time Frame: Baseline compared to 12 months post DC cardioversion ] [ Designated as safety issue: No ]
    Difference in correlation between left atrial size and function and neurohumoral or inflammatory biomarker levels pre/post cardioversion, when comparing early cardioversion to conventional treatment group.


Estimated Enrollment: 130
Study Start Date: November 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conventional
Conventional treatment Pradaxa prior to DC cardioversion
Drug: Pradaxa
Pradaxa for 3 weeks prior to DC
Experimental: TEE
Transesophageal echo prior to DC cardioversion (early DC)
Procedure: TEE
Transesophageal echo to exclude LAA thrombus, followed by early DC.
Active Comparator: Early versus Late DC cardioversion
Comparing early versus late DC cardioversion. Patients randomized to either early or late DC cardioversion, follow-up time after intervention 12 month.
Other: Compare TEE guided cardioversion to Dabigatran + DC cardioversion
compare the two groups, TEE followed by early DC cardioversion with Dabigatran for 3 weeks followed by DC cardioversion.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients admitted to department of cardiology OUH Svendborg Hospital or referred to outpatient clinic with symptomatic persistent AF, duration more than 48 hours and indication for DC cardioversion. Atrial fibrillation must be verified by a 12 lead ECG. All patients must be over 18 years of age, and must provide written informed consent prior to inclusion.

Exclusion Criteria:

  • Reversible causes for AF (thyrotoxicosis, infection, pulmonary embolism), acute coronary syndrome and absolute contraindications of TEE (oesophageal spasm, stricture, perforation and diverticula). Patients with diminished mental capability will not be included.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01593150

Locations
Denmark
OUH; Department of Medical Research, Svendborg Hospital Recruiting
Svendborg, Denmark, 5700
Contact: Armin Osmanagic, Dr.    0045 63202402    armin.osmanagic@OUH.regionsyddanmark.dk   
Sponsors and Collaborators
Odense University Hospital
  More Information

No publications provided

Responsible Party: Armin Osmanagic, Principal investigator, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01593150     History of Changes
Other Study ID Numbers: project nr.: S-20110075
Study First Received: May 2, 2012
Last Updated: May 9, 2012
Health Authority: Denmark : The Regional Scientific Ethical Committee for Southern Denmark

Keywords provided by Odense University Hospital:
Atrial Fibrillation
TEE
Early versus late DC cardioversion.

Additional relevant MeSH terms:
Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on April 15, 2014