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

NCT01593150 | Completed

• 1 other identifier: project nr.: S-20110075
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; TEE; Early versus late DC cardioversion.

Outcome Measures

Primary Outcomes (3)

• 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 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

  Baseline compared to 12 months post DC cardioversion

• Difference in time to recurrence of, ECG or Holter verified AF, when comparing early cardioversion to conventional treatment.

  Difference in time to recurrence of, ECG or Holter verified AF, when comparing early cardioversion to conventional treatment.

  Baseline compared to 12 months post DC cardioversion

• 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.

  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.

  Baseline compared to 12 months post DC cardioversion

Secondary Outcomes (1)

• 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.

  Baseline compared to 12 months post DC cardioversion

Study Arms (3)

Conventional

EXPERIMENTAL

Conventional treatment Pradaxa prior to DC cardioversion

Drug: Pradaxa

TEE

EXPERIMENTAL

Transesophageal echo prior to DC cardioversion (early DC)

Procedure: TEE

Early versus Late DC cardioversion

ACTIVE COMPARATOR

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

Interventions

Pradaxa DRUG

Pradaxa for 3 weeks prior to DC

Conventional

TEE PROCEDURE

Transesophageal echo to exclude LAA thrombus, followed by early DC.

TEE

Compare TEE guided cardioversion to Dabigatran + DC cardioversion OTHER

compare the two groups, TEE followed by early DC cardioversion with Dabigatran for 3 weeks followed by DC cardioversion.

Early versus Late DC cardioversion

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

OUH; Department of Medical Research, Svendborg Hospital

Svendborg, 5700, Denmark

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 2, 2012
• First Posted: May 8, 2012
• Study Start: November 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: February 3, 2015

Record last verified: 2015-02

Locations

DK (1)