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

Evaluation of Novel Biomarkers to Improve Risk Stratification and Patient Selection in ICD Therapy

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Germany
  • Hannover, Germany, 30625
    • Hannover Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICD therapy	ICD therapy (ATP/Shock) for ventricular fibrillation/ventricular tachycardia or inadequate therapy for supraventricular tachycardia/oversensing/lead dysfunction	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	MLWHFQ, EQ5D	2 years
Depression scale	PHQ-9	2 years
6-Minute-walk-test	6-Minute-walk-test	6 months
all-cause mortality	All-cause mortality	2 years
Heart Failure Events	Changes in NYHA classification, Hospitalizations	2 years
Risc Scores for Heart Failure events/ICD therapy	Seattle Heart Failure Model, Lee-Score, PROFIT-Score	2 years

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Investigators: Principal Investigator: David Duncker, MD, Hannover Medical School

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: May 7, 2012
• First Submitted That Met QC Criteria: May 7, 2012
• First Posted (Estimate): May 8, 2012

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: ventricular arrhythmias; cardiac death; implantable defibrillator
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death; Arrhythmias, Cardiac
• Other Study ID Numbers: BIOMARKER-ICD