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Dronedarone in Pacemakers Patients With Paroxysmal Atrial Fibrillation

2014-07-23 21:10:24 | BioPortfolio

Summary

The purpose of this study is to accurately investigate the efficacy of dronedarone in maintaining sinus rhythm and decreasing AFB in patients with paroxysmal atrial fibrillation as compared with placebo. This has never previously been performed using pacemaker Holter monitoring which provides detailed information of atrial arrhythmia patterns the entire study period. Additionally detailed patient symptom self assessment and questionnaires will be collected. The study design will be double blinded crossover with each phase lasting 3 months.

Description

The study is planned to commence in March 2010 after obtaining Ethics Committee approval. Patients will be randomised to a three month course of dronedarone or placebo. 1:1 double blinded randomisation will be undertaken. At three months, after a one week washout period, the patients will cross-over treatment groups. To achieve a power of 0.8 with a type one error rate 5% detecting a relative difference of 10% primary outcomes the study will require 42 patients. 50 patients in total will be enrolled in the study. The study will take place at Eastbourne District General Hospital. The study duration per patient is 7 months. The overall study duration will be 1 year.

STUDY OVERVIEW Appropriate patients with DDDRP pacemakers with an AF burden of 1-50% detected on pacemaker holters will be identified from the pacing clinic list and the Cardiology Outpatient Department at the Eastbourne District General Hospital. They will be invited to take part after a verbal explanation of the study has been given. If agreement is obtained each patient will be given the Patient Information Sheet and allowed time to consider their participation in the study and to ask relevant questions. If they are still in agreement they will be asked to sign the Patient Consent Form.

Initially, all patients will have all baseline parameters assessed. All patients will stop taking their anti-arrhythmic drugs for a period of one week. Patients will then have a three month course of either dronedarone or placebo according to randomisation in a double blinded fashion. Randomisation will be performed by use of random number tables. At three months data will be collected from patient questionnaires and pacemaker Holter.

There will be a one week washout period at this time. Patients will then cross-over to dronedarone or placebo for a three month period. Data from patient questionnaires and pacemaker Holters will be collected at three months after cross-over.

Patients will then undergo a further week washout period before re-initiating their original anti-arrhythmic therapy.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Paroxysmal Atrial Fibrillation

Intervention

Dronedarone, Placebo

Location

Eastbourne DGH
Eastbourne
East Sussex
United Kingdom
BN21 2UD

Status

Not yet recruiting

Source

Eastbourne General Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:10:24-0400

Clinical Trials [821 Associated Clinical Trials listed on BioPortfolio]

EURopean Trial In Atrial Fibrillation(AF) or Flutter (AFL) Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS)

To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation/atrial f...

Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy

Primary Objective: - Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular...

Comparison of Effectiveness of Ranolazine Plus Metoprolol Combination vs. FlecainidE pluS Metoprolol Combination in ATrial Fibrillation Recurrences FOllowing PhaRmacological or Electrical CardioverSion of AtRial Fibrillation

Atrial fibrillation (AF) is the most common arrhythmia in clinical practice with a prevalence reaching 5% in patients older than 65 years and an incidence that increases progressively with...

Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation

The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.

Effects of Dronedarone on Atrial Fibrillation Burden in Subjects With Permanent Pacemakers

The primary Objective of this study is to: - Evaluate the effects of dronedarone on Atrial Fibrillation (AF) burden (percent of time in which a subject is in AF) based on electrogram (EGM...

PubMed Articles [1992 Associated PubMed Articles listed on BioPortfolio]

Electrocardiographic Left Ventricular Hypertrophy Predicts Recurrence of Atrial Arrhythmias after Catheter Ablation of Paroxysmal Atrial Fibrillation.

Left ventricular hypertrophy (LVH) is an independent predictor of new-onset atrial fibrillation. Whether LVH can predict the recurrence of arrhythmia after radiofrequency catheter ablation (RFCA) in p...

Biomarkers determining prognosis of atrial fibrillation ablation.

Catheter ablation for rhythm control is recommended in specific patient populations with paroxysmal, persistent, or long-standing persistent atrial fibrillation. Pulmonary vein isolation is the corner...

Reply to the letter to the editor: "Left atrial low-voltage areas predict atrial fibrillation recurrence after catheter ablation in patients with paroxysmal atrial fibrillation".

Evaluation of P wave Dispersion and Tissue Doppler Imaging for Predicting Paroxysmal Atrial Fibrillation in Patients with Hypertension.

There are no previous studies dealing with paroxysmal atrial fibrillation (AF) and hypertension using electrocardiogram and tissue doppler imaging (TDI). The aim of this study was to investigate and i...

Concealed abnormal atrial phenotype in patients with Brugada syndrome and no history of atrial fibrillation.

The electrocardiogram (ECG) of patients with BrS in sinus rhythm might reflect intrinsic atrial electrical abnormalities independent from any previous atrial fibrillation (AF). Aim of this study is to...

Medical and Biotech [MESH] Definitions

Rapid, irregular atrial contractions caused by a block of electrical impulse conduction in the right atrium and a reentrant wave front traveling up the inter-atrial septum and down the right atrial free wall or vice versa. Unlike ATRIAL FIBRILLATION which is caused by abnormal impulse generation, typical atrial flutter is caused by abnormal impulse conduction. As in atrial fibrillation, patients with atrial flutter cannot effectively pump blood into the lower chambers of the heart (HEART VENTRICLES).

Long-term changes in the electrophysiological parameters and/or anatomical structures of the HEART ATRIA that result from prolonged changes in atrial rate, often associated with ATRIAL FIBRILLATION or long periods of intense EXERCISE.

A cardiotonic glycoside obtained mainly from Digitalis lanata; it consists of three sugars and the aglycone DIGOXIGENIN. Digoxin has positive inotropic and negative chronotropic activity. It is used to control ventricular rate in ATRIAL FIBRILLATION and in the management of congestive heart failure with atrial fibrillation. Its use in congestive heart failure and sinus rhythm is less certain. The margin between toxic and therapeutic doses is small. (From Martindale, The Extra Pharmacopoeia, 30th ed, p666)

A THROMBIN inhibitor which acts by binding and blocking thrombogenic activity and the prevention of thrombus formation. It is used to reduce the risk of stroke and systemic EMBOLISM in patients with nonvalvular atrial fibrillation.

A condition characterized by the recurrence of HEMOGLOBINURIA caused by intravascular HEMOLYSIS. In cases occurring upon cold exposure (paroxysmal cold hemoglobinuria), usually after infections, there is a circulating antibody which is also a cold hemolysin. In cases occurring during or after sleep (paroxysmal nocturnal hemoglobinuria), the clonal hematopoietic stem cells exhibit a global deficiency of cell membrane proteins.

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