Clinical Trial: Early Versus Late DC-cardioversion of Persistent Atrial Fibrillation. Effect on Atrial Remodeling,Inflammatory and Neurohumoral Markers and Recurrence of Atrial Fibrillation
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Early Versus Late DC-cardioversion of Persistent Atrial Fibrillation. Effect on Atrial Remodeling,Inflammatory and Neurohumoral Markers and Recurrence of Atrial Fibrillati
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
Detailed Summary:
Background:
Atrial fibrillation (AF) is the most common arrhythmia, present in about 1 % of the population under 60 years of age and significantly higher among the older population, reaching up to 15 % in patients at 80 years. Worldwide, the proportion of people aged over 60 years is growing faster than any other age group. This will inevitably result in an increased prevalence of AF in the overall population. This is supported by the fact that the incidence of AF has increased over the past two decades. Furthermore a number of diseases which are associated with a higher prevalence of AF, such as ischemic heart disease (IHD), valvular heart disease, diabetes and hypertension are also expected to increase in prevalence due to the aging population. This again will contribute to an increased incidence of AF. Atrial fibrillation is associated with significant increase in mortality, morbidity and a reduction in quality of life.
The mechanisms behind AF including proliferation of fibroblasts, enhanced connective tissue deposition and fibrosis, all play an important part in structural remodeling of the left atrium. The structural remodeling leads to electrical deterioration which is fundamental for initiation of AF. The persistence of AF induces further electrophysiological remodeling, shortening of atrial refractoriness and in the end persistence of AF. The vicious cycle can, be reversed by restoration of sinus rhythm.
The treatments available today range from DC cardioversion, pharmacological rhythm and rate control, radiofrequency ablation to anticoagulation treatment.
If rhythm control is desired, cardioversion to sinus rhythm is achievable by DC-cardioversion. If AF is present less than 48 hours DC-cardioversion can be perform
Sponsor: Odense University Hospital
Current Primary Outcome:
- 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 ]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 ]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 ]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.
Original Primary Outcome: Same as current
Current Secondary Outcome: 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 ]
Original Secondary Outcome: Same as current
Information By: Odense University Hospital
Dates:
Date Received: May 2, 2012
Date Started: November 2011
Date Completion:
Last Updated: February 2, 2015
Last Verified: February 2015
