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

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ClinicalTrials.gov Identifier: NCT01594073
Recruitment Status : Active, not recruiting
First Posted : May 8, 2012
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. David Duncker, Hannover Medical School

Brief Summary:

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 or disease
Ventricular Arrhythmias Cardiac Death

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Novel Biomarkers to Improve Risk Stratification and Patient Selection in ICD Therapy
Study Start Date : April 2012
Actual Primary Completion Date : August 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 :
  1. Quality of life [ Time Frame: 2 years ]
    MLWHFQ, EQ5D

  2. Depression scale [ Time Frame: 2 years ]
    PHQ-9

  3. 6-Minute-walk-test [ Time Frame: 6 months ]
    6-Minute-walk-test

  4. all-cause mortality [ Time Frame: 2 years ]
    All-cause mortality

  5. Heart Failure Events [ Time Frame: 2 years ]
    Changes in NYHA classification, Hospitalizations

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


Biospecimen Retention:   Samples With DNA
Serum, plasma (EDTA, heparin), monocytes, DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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
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Germany
Hannover Medical School
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Investigators
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Principal Investigator: David Duncker, MD Hannover Medical School
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Responsible Party: Dr. David Duncker, Principal Investigator, Hannover Medical School
ClinicalTrials.gov Identifier: NCT01594073    
Other Study ID Numbers: BIOMARKER-ICD
First Posted: May 8, 2012    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020
Keywords provided by Dr. David Duncker, Hannover Medical School:
implantable defibrillator
ventricular arrhythmias
cardiac death
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Death
Pathologic Processes
Heart Diseases
Cardiovascular Diseases