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

• Sponsor: Hannover Medical School (Other)
• Overall Status: Completed
• CT.gov ID: NCT01594073
• Collaborator: (none)
• Enrollment: 500
• Location: 1

Study Details

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	Intervention/Treatment	Phase
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
• Anticipated 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: Apr 1, 2012
• Actual Primary Completion Date: Aug 1, 2019

Outcome Measures

Primary Outcome Measures

1. 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

1. Quality of life [2 years]

   MLWHFQ, EQ5D

2. Depression scale [2 years]

   PHQ-9

3. 6-Minute-walk-test [6 months]

   6-Minute-walk-test

4. all-cause mortality [2 years]

   All-cause mortality

5. Heart Failure Events [2 years]

   Changes in NYHA classification, Hospitalizations

6. Risc Scores for Heart Failure events/ICD therapy [2 years]

   Seattle Heart Failure Model, Lee-Score, PROFIT-Score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	Hannover Medical School	Hannover		Germany	30625

Sponsors and Collaborators

• Hannover Medical School

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Feb 11, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Dr. David Duncker, Principal Investigator, Hannover Medical School: implantable defibrillator; ventricular arrhythmias; cardiac death
• Additional relevant MeSH terms: Arrhythmias, Cardiac; Death

Study Results

No Results Posted as of Feb 11, 2021