study of effective pharmacological cardioversion of paroxysmal atrial fibrillation with flecainide vs vernakalant

• Conditions: Atrial fibrillation paroxysmal; MedDRA version: 17.1Level: LLTClassification code 10003661Term: Atrial fibrillation paroxysmalSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-003641-95-ES
• Lead Sponsor: icasio Pérez Castellano

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-11
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1 Patients with paroxysmal atrial fibrillation with less of 48 hours of evolution.
2 Hemodynamically stable patients (systolic blood pressure> 100 mm Hg and <160 mm Hg. Diastolic blood pressure <95 mm Hg).
3 Weight from 45 to 136 kg.
4. Adequate anticoagulant therapy according to clinical practice guidelines of European Society of Cardiology in atrial fibrillation paroxysmal duration less of 48 hours.
5 Aging between 20 and 65 years old.
6 Patients must agree and be able to grant informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1 QT interval> 440 milliseconds, long QT familiar syndrome or previous history of Torsades de Pointes syndrome.
2 Symptomatic bradycardia or ventricular rate <50 bpm without a pacemaker, or QRS interval> 140 milliseconds.
3 Patients with Class IV heart failure according to the New York Heart Association or congestive heart failure requiring intravenous inotropic therapy.
4. cardiogenic or septic shock, chronic myocardial infarction, acute coronary syndrome, or heart surgery in <30 days before recruitment.
5 valve stenosis, obstructive hypertrophic cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis.
6. previous electrical cardioversion ineffective.
7 Having received an investigational drug within 60 days before inclusion or received vernakalant previously.
8 Secondary causes of atrial fibrillation, uncorrected electrolyte imbalance, or digoxin toxicity.
9 intravenous / oral treatment with class I or III antiarrhythmic drugs (except amiodarone) in the previous 48 hours.
10 intravenous / oral amiodarone within 3 months prior.
11 pregnant or nursing women.
12. intolerance or allergy to any of the two study drugs.
13 Patients who do not give their informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Effect of vernakalant and flecainide on the atrial activation and its relationship to effective cardioversion.;Secondary Objective: Evolution of the spectral parameters and rate of cardioversion in patients with less or more than 24 h after the beginning of the episode of paroxysmal AF. <br>Identification of new spectral and clinical predictors to estimate the probability of success of the drugs studied <br>Computational simulation using mathematical models of response in atrial fibrillation<br>Evaluate the clinical symptoms and patient perception during cardioversion strategy;Primary end point(s): yes no question cardioversion to sinus rhythm;Timepoint(s) of evaluation of this end point: 5,10,15,20,25,30,40,50,60,70,80 and 90 minutes after drug administration

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Demographic data: at the begining.<br>Related to drug safety: 5,10,15,20,25,30,40,50,60,70,80 and 90 minutes after drug administration.<br>Related to the perception of the patient: at the of the participation.;Secondary end point(s): Demographic data: age, weight, height, BMI, gender and personal history, cardiovascular risk factors, pulmonary diseases, chronic renal failure and others. <br>Related to drug safety: Respiratory complications, hemodynamic complications and other side effects. <br>Related to the perception of the patient: quality of life questionnaire (AF-QoL).