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Completed

NCT Number: NCT01594073

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

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Key information

Conditions

Ventricular Arrhythmias Cardiac Death Death Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hannover Medical School

Hanover, 30625, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. ICD therapy

    Time frame: 2 years

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

Secondary outcomes

  1. Quality of life

    Time frame: 2 years

    MLWHFQ, EQ5D

  2. Depression scale

    Time frame: 2 years

    PHQ-9

  3. 6-Minute-walk-test

    Time frame: 6 months

    6-Minute-walk-test

  4. all-cause mortality

    Time frame: 2 years

    All-cause mortality

  5. Heart Failure Events

    Time frame: 2 years

    Changes in NYHA classification, Hospitalizations

  6. Risc Scores for Heart Failure events/ICD therapy

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

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

Acronym: BIOMARKERICD

Important dates

Study start
2012
Primary completion
2019
First posted
May 8, 2012
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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