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

Cardiac Death Clinical Trial

— BIOMARKERICD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01594073
• Other study ID #: BIOMARKER-ICD
• Status: Completed
• Start date: April 2012

Study information

• Verified date: February 2021
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Death
• Death
• Ventricular Arrhythmias

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICD therapy	ICD therapy (ATP/Shock) for ventricular fibrillation/ventricular tachycardia or inadequate therapy for supraventricular tachycardia/oversensing/lead dysfunction	2 years
Secondary	Quality of life	MLWHFQ, EQ5D	2 years
Secondary	Depression scale	PHQ-9	2 years
Secondary	6-Minute-walk-test	6-Minute-walk-test	6 months
Secondary	all-cause mortality	All-cause mortality	2 years
Secondary	Heart Failure Events	Changes in NYHA classification, Hospitalizations	2 years
Secondary	Risc Scores for Heart Failure events/ICD therapy	Seattle Heart Failure Model, Lee-Score, PROFIT-Score	2 years