Premature ventricular beats, ventricular ectopy, ventricle tachycardia
Conditions
Interventions
Product Name: Sotalol
Pharmaceutical Form: Tablet
Product Name: Verapamil
Pharmaceutical Form: Tablet
Product Name: Flecainide
Pharmaceutical Form: Tablet
Sponsors
Maatschap Cardiologie Zwolle
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients willing and capable to provide written informed consent -Patients with frequent symptomatic VPB/VT and/or nonsustained VTs with a burden of = 5% on 24 hour Holter monitor AND -Absence of structural heart disease AND -Absence of underlying cardiac ischemia AND -Patient is considered an acceptable candidate for catheter ablation treatment with a dominant morphology of VPB/VT origin judged by the treating physician. -For those already undergoing treatment, all antiarrhythmic drugs including digitalis must be discontinued during a 2- week washout period before entry to the study 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 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90
Exclusion criteria
Exclusion criteria: -Age >75 years - Previous catheter ablation therapy for VPB/VT -Patients with sustained ventricular tachycardia or cardiac channelopathies (e.g. CPVT, long- or short QT syndrome, Brugada syndrome) -WPW syndrome - Use of medication with risk of QTc prolongation (e.g. antidepressant, antiemetic), except for study medication sotalol. - Left ventricular dysfunction (LV ejection fraction <55%) -Estimated glomerular filtration rate < 50 ml/min/1.73 m2 -Hepatic impairment defined by a total bilirubin = 2 times the upper limit (ULN) of normal ALAT or ASAT = 3 times ULN at screening. -Untreated hypo- or hyperthyroidism or electrolyte imbalance - Untreated obstructive sleep apnea -Patients with history of myocardial infarction or bypass surgery - More than grade 1/3 valvular regurgitation and/or significant valve stenosis (moderate or severe) - ontraindication for any of the antiarrhythmic drugs used in this study - Enrolment in another clinical study - Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertile age - Mental or physical inability to participate in the study -Life expectancy = 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to compare efficacy of antiarrhythmic drugs (sotalol or combination of flecainide and verapamil) and catheter ablation in reducing ventricular premature beats (VPB) burden in patients with symptomatic idiopathic VPB. ;Secondary Objective: 1. To explore the influence of different modulating factors on VPB/VT burden and response to treatment measured with change in absolute and relative VPB/VT burden and change in QoL and QALYs -Sympathetic drive, assessed by correlation between hourly VPB density and hourly HR during 24 hours ambulatory Holter monitoring -Gender differences in VPB/VT burden and response to different treatments -Effect of hormonal changes in women, by comparing VPB/VT burden and response to treatment in pre- and postmenopausal women. 2.To evaluate safety of investigational treatments. -The rate of adverse events related to catheter ablation -The rate of pro-arrhythmic effects of treatment with sotalol or combination of flecainide/verapamil. -The rate of VPB/VT-induced CMP in our study population by early detection of subtle changes in left ventricular function with the use of global longitudinal strain (GLS) ;Primary end point(s): Successful therapy, defined as >80 % reduction of VPB/VT burden and expressed in % of 24-hours ambulatory Holter monitoring period, after 3 months.;Timepoint(s) of evaluation of this end point: 3 months after start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Different time points, comparing baseline, 4-6 weeks, 3 months, 6 months and 1 year (*see E.5.2);Secondary end point(s): -QOL ranking using self-administered questionnaires in all patients, before (baseline) and after treatment (3 months, 6 months and 12 months) -Difference in VPB/VT burden at baseline between males and females and in females between pre- and postmenopausal women, expressed in % of 24 hour ambulatory Holter monitoring -Association between hourly VPB/VT density and hourly HR during 24-hours Holter- monitoring (VPB/VT frequency dependent on fast or slow HR or independent of HR) in all patients -Difference in VPB/VT burden reduction, expressed in % of 24-hours ambulatory Holter monitoring, after 3 months compared to 6 months in AAD arms. -Increase in VPB/VT burden with isoprenaline infusion during catheter ablation - Pro-arrhythmic effects, (non)-sustained VT or atrial flutter, in group A+ B with frequent visits and use of 24-hour Holter monitoring at 3 months, 6 months and 1 year -QTc prolongation (sotalol) and QRS broadening (flecainide) with requiring frequent checks with standard ECG and/or treadmill test 4-6 weeks after first administration of AAD. - Complication rate of catheter ablation in all patients with special interest to the subgroup of patients with anatomically challenging origin of (non-RVOT) VPB/VTs -Extended evaluation of left ventricular function with TTE (including global longitudinal strain rate measurement during sinus beats and during VPB/VT) at baseline and 12 months | — |
Countries
Netherlands
Contacts
Public ContactD.M.Haanschoten
Isala Zwolle
Outcome results
None listed