High dose statins in post-coarctectomy patients.
Phase 3
- Conditions
- Coarctationnarrowing of the aorta1001039410007510
- Registration Number
- NL-OMON31321
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
Post-coarctectomy patients
Exclusion Criteria
- Incapable of giving informed consent
- Hypersensitivity to atorvastatin or any of its help substances
- Current treatment with statins.
- Indication for treatment with statins based on the CBO-guideline for cardiovascular risk management.
- Raised plasma transaminases level > three times limiting value
- Raised CPK level > five times limiting value
- Myopathia
- Pregnant or nursing women (a pregnancy test is offered to every female patient within the fertile age) or desire to have children within the study period
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is change in carotid IMT, determined by<br /><br>ultrasonography.</p><br>
- Secondary Outcome Measures
Name Time Method <p>o the quality of life<br /><br>o the concentration of serum lipids<br /><br>o lipid lowering and time effects on the femoral vascular conduit<br /><br>o liver- and renal function<br /><br>o hypertension<br /><br>o disproportionate systolic hypertension with exercise (cardiovascular exercise<br /><br>testing)<br /><br>o exaggerated rise in systolic pressure in response to exercise (cardiovascular<br /><br>exercise testing)<br /><br>o left ventricular hypertrophy (echocardiography)<br /><br>o heart failure (echocardiography)<br /><br>o cerebrovascular accident<br /><br>o ruptured aortic aneurysm<br /><br>o aortic volume (MRI)<br /><br>o LVEDV, LVESV, EF, CO (MRI)<br /><br>o pulse wave velocity through the thoracic aorta (MRI)<br /><br>o extent of LV fibrosis (%) (MRI)<br /><br>o the number of deaths</p><br>