AVISO - Assessment of Flecainide versus Bisoprolol as First-Line Treatment for Premature Ventricular Contractions: a Multicenter Randomized Clinical Trial

Conditions

Premature ventricular contractions (PVC)

Brief summary

The primary endpoint is an efficacy endpoint: difference in daily Premature Ventricular Contractions (PVC) burden expressed in % of cardiac beats averaged from a 7-days Holter-ECG monitoring, between the inclusion and the 3 months follow-up periods.

Detailed description

Incidence of the adverse events listed below evaluated at 3 months. • Major: death from any cause, hospitalization for cardiovascular causes, sustained ventricular arrhythmia, fast-conducting (1:1) atrial arrhythmias. • Minor: fatigue, vertigo, blurred vision, tremor, impotence, hypotension or symptomatic sinus bradycardia < 50 bpm, QRS widening >120 ms., Difference in Quality of Life assessed by the European Quality of Life–5 Dimensions (EQ-5D) visual analogue scale and the 12-Item Short-Form General Health Survey (SF- 12), between baseline and after 3 months of treatment., Need for catheter ablation of PVC., Efficacy endpoint (primary endpoint) in specific subtypes such as papillary muscle PVCs, LV summit or multifocal PVCs.

Related papers

No related papers found yet.

Interventions

DRUGFLECAINIDE

DRUGBISOPROLOL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is an efficacy endpoint: difference in daily Premature Ventricular Contractions (PVC) burden expressed in % of cardiac beats averaged from a 7-days Holter-ECG monitoring, between the inclusion and the 3 months follow-up periods.	—

Secondary

Measure	Time frame
Incidence of the adverse events listed below evaluated at 3 months. • Major: death from any cause, hospitalization for cardiovascular causes, sustained ventricular arrhythmia, fast-conducting (1:1) atrial arrhythmias. • Minor: fatigue, vertigo, blurred vision, tremor, impotence, hypotension or symptomatic sinus bradycardia < 50 bpm, QRS widening >120 ms., Difference in Quality of Life assessed by the European Quality of Life–5 Dimensions (EQ-5D) visual analogue scale and the 12-Item Short-Form General Health Survey (SF- 12), between baseline and after 3 months of treatment., Need for catheter ablation of PVC., Efficacy endpoint (primary endpoint) in specific subtypes such as papillary muscle PVCs, LV summit or multifocal PVCs.	—

Measure

Time frame

Incidence of the adverse events listed below evaluated at 3 months. • Major: death from any cause, hospitalization for cardiovascular causes, sustained ventricular arrhythmia, fast-conducting (1:1) atrial arrhythmias. • Minor: fatigue, vertigo, blurred vision, tremor, impotence, hypotension or symptomatic sinus bradycardia < 50 bpm, QRS widening >120 ms., Difference in Quality of Life assessed by the European Quality of Life–5 Dimensions (EQ-5D) visual analogue scale and the 12-Item Short-Form General Health Survey (SF- 12), between baseline and after 3 months of treatment., Need for catheter ablation of PVC., Efficacy endpoint (primary endpoint) in specific subtypes such as papillary muscle PVCs, LV summit or multifocal PVCs.

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Outcome results

None listed