Coarctation narrowing of the aorta
Conditions
Interventions
One group daily receives a 80 mg tablet of atorvastatine, the other group will
not get a statin or placebo.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Post-coarctectomy patients
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is change in carotid IMT, determined by ultrasonography. | — |
Secondary
| Measure | Time frame |
|---|---|
| o the quality of life o the concentration of serum lipids o lipid lowering and time effects on the femoral vascular conduit o liver- and renal function o hypertension o disproportionate systolic hypertension with exercise (cardiovascular exercise testing) o exaggerated rise in systolic pressure in response to exercise (cardiovascular exercise testing) o left ventricular hypertrophy (echocardiography) o heart failure (echocardiography) o cerebrovascular accident o ruptured aortic aneurysm o aortic volume (MRI) o LVEDV, LVESV, EF, CO (MRI) o pulse wave velocity through the thoracic aorta (MRI) o extent of LV fibrosis (%) (MRI) o the number of deaths | — |
Countries
Netherlands
Outcome results
None listed