Evaluation of Novel Biomarkers to Improve Risk Stratification and Patient Selection in Implantable Cardioverter-defibrillator (ICD) Therapy (BIOMARKERICD)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Evaluation of Novel Biomarkers to Improve Risk Stratification and Patient Selection in ICD Therapy|
- ICD therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]ICD therapy (ATP/Shock) for ventricular fibrillation/ventricular tachycardia or inadequate therapy for supraventricular tachycardia/oversensing/lead dysfunction
- Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Depression scale [ Time Frame: 2 years ] [ Designated as safety issue: No ]PHQ-9
- 6-Minute-walk-test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- all-cause mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Heart Failure Events [ Time Frame: 2 years ] [ Designated as safety issue: No ]Changes in NYHA classification, Hospitalizations
- Risc Scores for Heart Failure events/ICD therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]Seattle Heart Failure Model, Lee-Score, PROFIT-Score
- Puls wave velocity [ Time Frame: at inclusion ] [ Designated as safety issue: No ]Only patients getting the first implantation of ICD.
Biospecimen Retention: Samples With DNA
Serum, plasma (EDTA, heparin), monocytes, DNA
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594073
|Contact: David Duncker, MDfirstname.lastname@example.org|
|Hannover Medical School||Recruiting|
|Hannover, Germany, 30625|
|Contact: David Duncker, MD +495115323817 email@example.com|
|Principal Investigator: David Duncker, MD|
|Principal Investigator:||David Duncker, MD||Hannover Medical School|
|Study Director:||Hanno Oswald, MD||Hannover Medical School|