Anti Arrhythmic Therapies and Sudden Cardiac Deaths

Study Overview
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Brief Summary
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Failing heart negative remodeling alterations might provide electrical heterogeneity and cardiac remodeling, thus potentially contributing to the occurrence of ventricular arrhythmia and subsequent sudden cardiac death (SCD). In this study we have prospectively investigated whether serum markers of heart failure (ultra sensitive Troponin , B type Natriuretic Peptide (BNP), C reactive protein (CRP), ST protein, and adiponectin could be used as predictors for the occurrence of malignant ventricular arrhythmias in patients who had received an Implantable Cardioverter Defibrillator (ICD) for primary prevention and treated by catheter ablation for ventricular arrhythmias.

Official Title
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New Failing Heart Serum Biomarkers ro Predict Anti Arrhythmic Therapies and Sudden Cardiac Death in Implantable Cardioverter Defibrillators (ICDs) Recipients

Conditions
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ICD, Heart Failure, Sudden Cardiac Death

Intervention / Treatment
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* Device: internal cardioverter defibrillator implant (ICD)
* Procedure: percutaneous catheter ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stable heart failure; indication for a ICD and/or a CRT-d system; NYHA Class II-III; left ventricle ejection fraction <35%; patients receiving optimal medical therapy. Exclusion Criteria: NYHA Class I, and IV; co-morbidities which may limit life to <6 months; history of cardiac surgery or intervention within the preceding 90 days; history of moderate to severe chronic obstructive pulmonary disease (COPD), defined as needing chronic oxygen therapy, or recent (within 30 days) hospitalization for COPD flare-up; pregnancy; history of primary pulmonary hypertension.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| heart failure patients<br> | Device: internal cardioverter defibrillator implant (ICD)<br>* to implant ICD in failing heart subjects with reduced left ventricle ejection fraction (LVEF < 35%).<br>Procedure: percutaneous catheter ablation<br>* to perform catheter ablation in patients with heart failure and reduced left ventricle ejection fraction (LVEF < 35%).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause deaths | authors will report all cause of deaths by hospital discarge schedules, visits, telephonic interviews, and deaths registry. | 12 months | 
| cardiac deaths | authors will report cardiac deaths by hospital discarge schedules, visits, telephonic interviews, and deaths registry. | 12 months | 
| Heart failure hospitalization | authors will report heart failure hospitalization by hospital discarge schedules, visits, telephonic interviews. | 12 months | 
| ICDs' intervention | authors will report ICDs' intervention by hospital discarge schedules, visits, telephonic interviews, and telemetric devices interrogations. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arrhythmic burden | authors will report arrhythmic burden by hospital discarge schedules, visits, telephonic interviews, egg hollering, and telemetric devices interrogations. | 12 months |