The aim of this study is to investigate to what extent biomarkers are related to the development of ventricular arrhythmias, in order to improve the indication for ICD therapy.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The expression of biomarkers in the serum of patients with and without
appropriate therapy.
Secondary outcome
To determine novel biomarkers that may be associated with the onset of
ventricular arrhythmias. This is done through proteomics. The patients with
appropriate therapy are matched with patients without appropriate therapy.
Subsequently, the protein profile is determined in both groups in order to see
whether there are proteins that are elevated in the group with an arrhythmia
and not in the group without an arrhythmia.
Background summary
Sudden cardiac death accounts for about 20% of all deaths in Europe. The
implantable cardioverter defibrillator is designed to deliver a shock in the
event of a fatal cardiac arrhythmia. An ICD is currently being implanted in
several groups of patients who have an increased risk of developing a lethal
ventricular arrhythmia. Currently, the most commonly used and known risk factor
is having reduced left ventricular function measured as ejection fraction
(LVEF). However, only a limited number of patients with an ICD actually develop
an arrhythmia, while they are exposed to a risk of complications. In addition,
there is still a group of people who die of sudden cardiac death without the
protection of an ICD. In this study we look for potential biomarkers that are
predictive of the occurrence of ventricular arrhythmias.
Study objective
The aim of this study is to investigate to what extent biomarkers are related
to the development of ventricular arrhythmias, in order to improve the
indication for ICD therapy.
Study design
Blood will be drawn during routine follow-up of patients with an ICD. This will
happen at baseline, 6 and 12 months. If a patient receives appropriate therapy,
blood will be taken 1 more time within two weeks after this therapy. These
patients are matched on the basis of baseline characteristics to patients
without appropriate therapy. In both groups, the levels of biomarkers are
determined and it is examined whether they are elevated in the patients with
therapy.
Study burden and risks
Patients will not directly benefit from this study. However, there is only a
very small risk of complications associated with the collection of blood. This
includes hematoma formation or scar tissue. The blood tests are linked as much
as possible to visits for standard care.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Patients with a primary prevention ICD, according to current EU guidelines
- Patients with no prior documented treated or untreated sustained ventricular
arrhythmias
- >=18 years of age
Exclusion criteria
- Transvenous ICD implanted less than 3 months prior to inclusion
- Contra-indications for venepunctures
- CRT-D patients
- Patients with an ICD indication based on a channelopathy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83370.015.23 |