1) Premature ventricular complex induced cardiomyopathy 2) Heart failure due to ectopic heart beats
Conditions
Interventions
Patients will be randomized into 2 groups. One group will receive PVC
suppression therapy on top of conventional heart failure therapy. The other
group will receive conventional heart failure therap
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - CMP (LVEF 6 months. - Optimal conventional heart failure therapy > 3 months. - Frequent monomorphic PVCs on Holter monitoring. * Frequent
Exclusion criteria
Exclusion criteria: - Other causes of LV systolic dysfunction: * Significant valvular disease * Untreated hypertension (blood pressure > 140 mmHg) * Primary CMP (HCM, ARVC, LVNC, myocarditis, stress, peripartum) * Secondary CMP (infiltrative, storage, toxic, neuromuscular/neurological, autoimmune) - Electrocardiographic PVC characteristics suggestive of a focal origin not accessible by percutaneous approach. - Sustained supra-ventricular arrhythmia. - Evidence of significant CAD (>70% stenosis of a coronary artery) on coronary angiogram (CAG) or coronary CT necessitating revascularization (PCI / CABG) in the foreseeable future. - Signs of current myocardial ischemia on ECG (dynamic STT segments) or during exercise testing (significant ST segment depression/elevation). - Myocardial infarction within the last 6 calender months prior to enrollment. - PCI / CABG within the last 6 calender months prior to enrollment. - Physical status not allowing electrophysiological study (e.g. pregnancy or severe peripheral artery disease) - Presence of any disease, other than the patients cardiac disease, associated with a reduced likelihood of survival for the duration of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change in cardiac function using the echocardiographic parameter: Left ventricular ejection fraction (LVEF), assessed by modified Simpsons* rule at baseline versus 6 months follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Absolute change in cardiac function using other echocardiographic parameters: Left Ventricular End-Diastolic Diameter (LVEDD), Left Ventricular End-Systolic Diameter (LVESD), Left Ventricular End-Diastolic Volume (LVEDV) and Left Ventricular End-Systolic Volume (LVESV) at baseline versus 6 months follow-up. * Absolute change in functional capacity, using NYHA functional class at baseline versus 6 months follow-up. * Absolute change in exercise tolerance, using 6 minute walking distance at baseline versus 6 months follow-up. * Absolute change in patient QoL, using the Minnesota Living with Heart Failure questionnaire score at baseline versus 6 months follow-up. * Absolute change in NT-proBNP level, using plasma NT-proBNP level at baseline versus 6 months follow-up. * Absolute change in PVC burden, using PVC frequency at baseline versus 6 months follow-up. * Number and sort of complications of PVC suppression therapy. * Cost-effectiveness: costs from a health service perspective during one year follow-up and effectiveness measured as quality adjusted life years (QALY). | — |
Countries
Netherlands
Outcome results
None listed