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

NCT01594073 | Completed

• 1 other identifier: BIOMARKER-ICD
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Arrhythmias; Cardiac Death

Keywords

implantable defibrillator; ventricular arrhythmias; cardiac death

Outcome Measures

Primary Outcomes (1)

• ICD therapy

  ICD therapy (ATP/Shock) for ventricular fibrillation/ventricular tachycardia or inadequate therapy for supraventricular tachycardia/oversensing/lead dysfunction

  2 years

Secondary Outcomes (6)

• Quality of life

  2 years

• Depression scale

  2 years

• 6-Minute-walk-test

  6 months

• all-cause mortality

  2 years

• Heart Failure Events

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient meeting the current indications for primary or secondary prophylactic ICD/CRT-D therapy
• age 18 years or older

You may not qualify if:

• Patient unwilling to participate.

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma (EDTA, heparin), monocytes, DNA

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Duncker, MD

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: May 8, 2012
• Study Start: April 1, 2012
• Primary Completion: August 1, 2019
• Last Updated: February 11, 2021

Record last verified: 2021-02

Locations

DE (1)