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

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

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
• Other Study ID Numbers: BIOMARKER-ICD
• First Posted: May 8, 2012
• 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:

Arrhythmias, Cardiac; Death; Pathologic Processes; Heart Diseases; Cardiovascular Diseases