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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Hannover Medical School
Sponsor:
Information provided by (Responsible Party):
Dr. David Duncker, Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01594073
First received: May 7, 2012
Last updated: February 3, 2013
Last verified: February 2013
  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 Hannover Medical School:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01594073

Contacts
Contact: David Duncker, MD +495115323817 duncker.david@mh-hannover.de

Locations
Germany
Hannover Medical School Recruiting
Hannover, Germany, 30625
Contact: David Duncker, MD    +495115323817    duncker.david@mh-hannover.de   
Principal Investigator: David Duncker, MD         
Sponsors and Collaborators
Hannover Medical School
Investigators
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 July 22, 2014