This study will test the hypothesis that acute administration of statins will provide for a better protective (anti-inflammatory) effect than chronic administration. Patients used for this study have to undergo mitral and/or tricuspid valve surgery…
ID
Source
Brief title
Condition
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
CRP, IL-6, ICAM1, vWF, cytokines, p-selectin, CK, troponins
Secondary outcome
n/a
Background summary
Medical research has shown that statins, in addition to their effects on the
cholestrol metabolism, also have an anti-inflammatory effect. Animal studies
show that the infarct size is significantly reduced after myocardial ischemia
by statins. The immune respons elicited by the ischemia is repressed by
statins. This protective effect is probably at it's best when statins are
administered just before the ischemic period; the anti-inflammatory effects
wear off and vanish as statins are administered chronically. This knowledge
holds clinically relevant information. In order to investigate whether these
differences (acute versus chronic administration) also occur in humans we will
administer statins per-operatively to patients in need of open heart surgery.
Open heart surgery is an excellent model for ischemia as the blood supply to
the heart will be impaired for part of the operation thus eliciting myocardial
ischemia. During this study the difference in protection between the acute and
chronic administrion of statins will be measured using myocardial ischemia
reperfusion injury markers.
Study objective
This study will test the hypothesis that acute administration of statins will
provide for a better protective (anti-inflammatory) effect than chronic
administration. Patients used for this study have to undergo mitral and/or
tricuspid valve surgery and thus will have no history of statin use.
If the hypothesis proves to be valid, pre-operative administration for open
heart surgery needs to be considered as well as giving patients, receiving
statins, in need of open heart surgery a drug-holiday.
Study design
40 patients will be randomized into 2 different groups; one of the groups will
receive acute pre-operative administration of statins, the other group will
receive a long term (at least 2 weeks) pre-operative administration of statins.
The results of both groups will be compared to results from other patients who
underwent the same operation but without the pre-operative treatment with
statins.
Intervention
simvastatin 40mg
group 1: one dose of 40mg the evening before, and one dose of 40mg the morning
of the operation
group 2: one dose of 40mg a day starting a minimum of 14 days before the
operation
Study burden and risks
low.
Postbus 9600
2300RC Leiden
NL
Postbus 9600
2300RC Leiden
NL
Listed location countries
Age
Inclusion criteria
open mitral and/or tricuspid valve surgery
Exclusion criteria
• Statine use
• Acceptation for minimal invasive mitral valve surgery
• Inability to sign informed consent
• Less than 18 years old
• Ablation procedures
• Emergency operations
• Clinically diagnosed heart failure
• Clinically diagnosed atherosclerosis
• CABG procedures
• Use of corticosteroids (e.g. prednisone etc.)
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 |
|---|---|
| EudraCT | EUCTR2009-018221-79-NL |
| CCMO | NL31175.058.10 |