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

Completed

• Conditions: Cardiac Death; Ventricular Arrhythmias

• Registration Number: NCT01594073
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-05-07
• Study First Submitted QC: 2012-05-07
• Study First Posted: 2012-05-08
• Primary Completion: 2019-08
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ICD therapy	2 years	ICD therapy (ATP/Shock) for ventricular fibrillation/ventricular tachycardia or inadequate therapy for supraventricular tachycardia/oversensing/lead dysfunction

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, Germany