Our first objective is obtaining hypertrophic myocardial tissue for identifying novel biomarker, indicative and predictive for the severity of cardiac hypertrophy. Our second objective is validation of biomarkers detected in previous studies.
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
identifying proteins involved in myocardial hypertrophy
Secondary outcome
validation of biomarkers in hypertrophic myocardial tissue
Background summary
The presence of left ventricular hypertrophy is clinically important since it
is a strong independent risk predictor of heart failure1. Left ventricular
hypertrophy (LVH) is also associated with an increased risk for developing
ventricular and atrial arrhythmias, coronary artery disease (myocardial
infarction) and cardiovascular death.Several studies have already determined
the possibility of left ventricular mass reduction, using different blood
pressure lowering therapeutic agents as ACE-inhibitors, AT-2 inhibitors and
beta-blocking therapy, which also improves clinical outcome. LVH development is
associated with the induction of altered genetic programming. Animal studies
have researched if left ventricular function improves by inhibiting LVH, using
the knowledge of the different hypertrophy pathways. What stands out:
decreasing left ventricular hypertrophy results in improved left ventricular
function and thus clinical outcome. ECG-criteria and 2-D echocardiography is
most often used to detect LVH. Although the accuracy of 2-D echocardiography is
0.905, the standard error of the estimate is 38.5 g. This means, not only that
ultrasound can miss LVH, but also that small differences in left ventricular
(LV) mass, caused by treatment can be left undetected. Biomarkers for
hypertrophy could possibly determine therapeutic effects of different
antihypertensive agents more reliably. In addition, in a rat model it is found
that intervening in LVH to improve LV-function, works more efficiently when
intervening early in disease. Biomarkers for hypertrophy could then possibly
detect LVH much earlier than the now used ECG-criteria and echocardiography and
thus leading to improved outcome. In addition, biomarkers could be used to
predict the outcome post surgery as in some pts the heart is beyond repair.
Study objective
Our first objective is obtaining hypertrophic myocardial tissue for identifying
novel biomarker, indicative and predictive for the severity of cardiac
hypertrophy. Our second objective is validation of biomarkers detected in
previous studies.
Study design
This study is designed as an monocenter observational study. Patients planned
for aortic valve surgery will be approached for participation. During surgery
myocardial tissue is obtained. One half of tissue will be snap frozen in liquid
nitrogen and stored at -80°C for further analysis. The other half of myocardial
tissue will be placed in NaCl 0.9%, and taken to the experimental cardiology
laboratory for protein analysis and storage. For further description of tissue
analysis, see Protocol page 2.
Study burden and risks
Patients are asked to undergo myocardial biopsy during their already planned
surgery. According to the thoracic surgeons this does not lead to any
additional risk for the patient. Patients will not be contacted again after
their surgery. We think the risk and burden for the patients are thus very
small and since we*re gaining a huge amount of scientific knowledge considering
left ventricular hypertrophy and probably a new and easy diagnostic tool we
think this is justified.
Heidelberglaan 100
3508 GA Utrecht
Nederland
Heidelberglaan 100
3508 GA Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Patients are included in this study when planned for surgical aortic valve replacement for severe aortic valve stenosis. Signs of left ventricular hypertrophy have to be present either on ECG, echocardiography or MRI. None of the exclusion criteria are met. Written informed consent is obtained.
Exclusion criteria
Patients with concomitant heart disease: previous myocardial infarction, endocarditis. Patients younger than 18 years of age are also excluded from participation in this study. Patients who have a syndromic or genetic diagnosis, for example, Marfan*s disease, trisomy 21, and Turner*s syndrome
Design
Recruitment
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 | NL22028.041.08 |