Evaluation of Novel Biomarkers to Improve Risk Stratification and Patient Selection in Implantable Cardioverter-defibrillator (ICD) Therapy

Study Overview
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Brief Summary
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Implantable cardioverter-defibrillator (ICD) therapy reduces mortality in patients with chronic heart failure and reduced left ventricular ejection fraction (LVEF) <36%. Nevertheless, patient selection for ICD therapy based on LVEF and NYHA functional class alone seems to have a low specificity and sensitivity: In 100 patients treated, the SCD-HeFT study prevented 7 deaths in 5 years. Therefore 93 patients have a risk of adverse effects, such as operation risk, infection, pneumothorax, lead dislocation, and inadequate icd therapy. On the other hand, patients with advanced or end stage heart failure might rather die off progressive heart failure death and thus not benefit from ICD therapy. It therefore seems appropriate and necessary to improve the individualized risk stratification in these patients. The aim of this study is to evaluate multiple cardiac biomarkers in a model predicting ventricular arrhythmias in patients on ICD therapy.

Detailed Description
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Patients having or getting an ICD in the Dept. of Cardiovascular Medicine of the Hannover Medical School will be recruited in the next 2 years. Blood samples of all patients will be obtained at inclusion and at 6 months follow-up. Patients will be followed-up for 1-2 years after inclusion.

Official Title
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Evaluation of Novel Biomarkers to Improve Risk Stratification and Patient Selection in ICD Therapy

Conditions
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Ventricular Arrhythmias, Cardiac Death

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient meeting the current indications for primary or secondary prophylactic ICD/CRT-D therapy age 18 years or older Exclusion Criteria: Patient unwilling to participate.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICD therapy | ICD therapy (ATP/Shock) for ventricular fibrillation/ventricular tachycardia or inadequate therapy for supraventricular tachycardia/oversensing/lead dysfunction | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | MLWHFQ, EQ5D | 2 years | 
| Depression scale | PHQ-9 | 2 years | 
| 6-Minute-walk-test | 6-Minute-walk-test | 6 months | 
| all-cause mortality | All-cause mortality | 2 years | 
| Heart Failure Events | Changes in NYHA classification, Hospitalizations | 2 years | 
| Risc Scores for Heart Failure events/ICD therapy | Seattle Heart Failure Model, Lee-Score, PROFIT-Score | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implantable defibrillator, ventricular arrhythmias, cardiac death