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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01594073
First Posted: May 8, 2012
Last Update Posted: August 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. David Duncker, Hannover Medical School
  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

Resource links provided by NLM:


Further study details as provided by Dr. David Duncker, Hannover Medical School:

Primary Outcome Measures:
  • ICD therapy [ Time Frame: 2 years ]
    ICD therapy (ATP/Shock) for ventricular fibrillation/ventricular tachycardia or inadequate therapy for supraventricular tachycardia/oversensing/lead dysfunction


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 2 years ]
  • Depression scale [ Time Frame: 2 years ]
    PHQ-9

  • 6-Minute-walk-test [ Time Frame: 6 months ]
  • all-cause mortality [ Time Frame: 2 years ]
  • Heart Failure Events [ Time Frame: 2 years ]
    Changes in NYHA classification, Hospitalizations

  • Risc Scores for Heart Failure events/ICD therapy [ Time Frame: 2 years ]
    Seattle Heart Failure Model, Lee-Score, PROFIT-Score

  • Puls wave velocity [ Time Frame: at inclusion ]
    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: December 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Detailed Description:
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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients reveicing or having received an implantable cardioverster-defibrillator in the Dept. of Cardiovascular Medicine of the Hanover Medical School.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594073


Locations
Germany
Hannover Medical School
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Investigators
Principal Investigator: David Duncker, MD Hannover Medical School
  More Information

Responsible Party: Dr. David Duncker, Principal Investigator, Hannover Medical School
ClinicalTrials.gov Identifier: NCT01594073     History of Changes
Other Study ID Numbers: BIOMARKER-ICD
First Submitted: May 7, 2012
First Posted: May 8, 2012
Last Update Posted: August 16, 2017
Last Verified: August 2017

Keywords provided by Dr. David Duncker, Hannover Medical School:
implantable defibrillator
ventricular arrhythmias
cardiac death

Additional relevant MeSH terms:
Death
Pathologic Processes