Evaluation of Novel Biomarkers to Improve Risk Stratification and Patient Selection in Implantable Cardioverter-defibrillator (ICD) Therapy (BIOMARKERICD)
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Purpose
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.
| Condition |
|---|
|
Ventricular Arrhythmias Cardiac Death |
| Study Type: | Observational |
| 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
| Estimated Enrollment: | 500 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients reveicing or having received an implantable cardioverster-defibrillator in the Dept. of Cardiovascular Medicine of the Hanover Medical School.
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.
Contacts and Locations| Contact: David Duncker, MD | +495115323817 | duncker.david@mh-hannover.de |
| Germany | |
| Hannover Medical School | Recruiting |
| Hannover, Germany, 30625 | |
| Contact: David Duncker, MD +495115323817 duncker.david@mh-hannover.de | |
| Principal Investigator: David Duncker, MD | |
| Principal Investigator: | David Duncker, MD | Hannover Medical School |
| Study Director: | Hanno Oswald, MD | Hannover Medical School |
More Information
No publications provided
| Responsible Party: | Dr. David Duncker, Principal Investigator, Hannover Medical School |
| ClinicalTrials.gov Identifier: | NCT01594073 History of Changes |
| Other Study ID Numbers: | BIOMARKER-ICD |
| Study First Received: | May 7, 2012 |
| Last Updated: | February 3, 2013 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Hannover Medical School:
|
implantable defibrillator ventricular arrhythmias cardiac death |
Additional relevant MeSH terms:
|
Arrhythmias, Cardiac Death Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013