Ventricular ArrhythmiasBIOMARKERICDNCT01594073
Evaluation of Novel Biomarkers to Improve Risk Stratification and Patient Selection in Implantable Cardioverter-defibrillator (ICD) Therapy
An observational study of Ventricular Arrhythmias and Cardiac Death, run by Hannover Medical School at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Arrhythmias, Cardiac Death
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2012to Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients reveicing or having received an implantable cardioverster-defibrillator in the Dept. of Cardiovascular Medicine of the Hanover Medical School.
Who may be able to join
- Patient meeting the current indications for primary or secondary prophylactic ICD/CRT-D therapy
- age 18 years or older
Who cannot join
- Patient unwilling to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ventricular Arrhythmias, Cardiac Death
- Keywords
- implantable defibrillator, ventricular arrhythmias, cardiac death
- Medical subject headings
- Death
What is being measured
The primary outcome is the main question the study is designed to answer.
ICD therapy
ICD therapy (ATP/Shock) for ventricular fibrillation/ventricular tachycardia or inadequate therapy for supraventricular tachycardia/oversensing/lead dysfunction
Measured: 2 years
Secondary outcomes (6)
Quality of life
MLWHFQ, EQ5D
Measured: 2 years
Depression scale
PHQ-9
Measured: 2 years
6-Minute-walk-test
6-Minute-walk-test
Measured: 6 months
all-cause mortality
All-cause mortality
Measured: 2 years
Heart Failure Events
Changes in NYHA classification, Hospitalizations
Measured: 2 years
Risc Scores for Heart Failure events/ICD therapy
Seattle Heart Failure Model, Lee-Score, PROFIT-Score
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrhythmiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. David Duncker, Hannover Medical School
- Investigators
- David Duncker, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594073
- Sponsor's protocol ID
- BIOMARKER-ICD
- Acronym
- BIOMARKERICD
- Status last verified
- Feb 2021
- First submitted
- 7 May 2012
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Novel Biomarkers to Improve Risk Stratification and Patient Selection in ICD Therapy
- ClinicalTrials.gov ID
- NCT01594073
- Acronym / sponsor ID
- BIOMARKERICD / BIOMARKER-ICD
- Conditions
- Ventricular Arrhythmias, Cardiac Death
- Keywords
- implantable defibrillator, ventricular arrhythmias, cardiac death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Aug 2019 (actual)
- First posted
- 8 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients reveicing or having received an implantable cardioverster-defibrillator in the Dept. of Cardiovascular Medicine of the Hanover Medical School.
Key inclusion criteria (2 listed)
- Patient meeting the current indications for primary or secondary prophylactic ICD/CRT-D therapy
- age 18 years or older
Key exclusion criteria (1 listed)
- Patient unwilling to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ICD therapy
Time frame: 2 years
ICD therapy (ATP/Shock) for ventricular fibrillation/ventricular tachycardia or inadequate therapy for supraventricular tachycardia/oversensing/lead dysfunction
6 secondary outcomes
Quality of life
Time frame: 2 years
Depression scale
Time frame: 2 years
6-Minute-walk-test
Time frame: 6 months
all-cause mortality
Time frame: 2 years
Heart Failure Events
Time frame: 2 years
Risc Scores for Heart Failure events/ICD therapy
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
Related trials for Ventricular Arrhythmias
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
RecruitingObservational study
Physical Impairments in Premature Ventricular Complex
Premature Ventricular Complexes
Recruiting
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias
Arrhythmias, Cardiac
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Duncker, MD principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Arrhythmias and Cardiac Death, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICD therapy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.