High dose statins in post-coarctectomy patients.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22766

Enrollment

150

Registered

2007-09-18

Start date

2007-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis in post-coarctectomy patients.

Interventions

Atorvastatin 80 mg once a day.

Eligibility

Inclusion criteria

Inclusion criteria: Post-coarctectomy patients.

Exclusion criteria

Exclusion criteria: 1. Incapable of giving informed consent; 2. Hypersensitivity to atorvastatin or any of its help substances; 3. Current treatment with anti-lipaemic drugs; 4. Indication for treatment with statins based on the CBO-guideline for cardiovascular risk management; 5. Raised plasma transaminases level > three times limiting value; 6. Raised CPK level > five times limiting value; 7. Myopathia; 8. Pregnant or nursing women (a pregnancy test is offered to every female patient within the fertile age); 9. Desire to have children within the study period.

Design outcomes

Primary

Measure	Time frame
IMT.	—

Secondary

Measure	Time frame
1. The quality of life; 2. The concentration of serum lipids; 3. Lipid lowering and time effects on the femoral vascular conduit; 4. Liver- and renal function; 5. Microcirculation (FMD); 6. Hypertension; 7. Disproport onate systolic hypertension with exercise (cardiovascular exercise testing); 8. Exaggerated rise in systolic pressure in response to exercise (cardiovascular exercise testing); 9. Left ventricular hypertrophy (echocardiography); 10. Heart failure (echocardiography); 11. Cerebrovascular accident; 12. Ruptured aortic aneurysm; 13. Aortic volume (MRI); 14. LVEDV, LVESV, EF, CO (MRI); 15. Pulse wave velocity through the thoracic aorta (MRI); 16. Extent of LV fibrosis (%) (MRI); 17. The number of deaths.	—

Measure

Time frame

1. The quality of life; 2. The concentration of serum lipids; 3. Lipid lowering and time effects on the femoral vascular conduit; 4. Liver- and renal function; 5. Microcirculation (FMD); 6. Hypertension; 7. Disproport onate systolic hypertension with exercise (cardiovascular exercise testing); 8. Exaggerated rise in systolic pressure in response to exercise (cardiovascular exercise testing); 9. Left ventricular hypertrophy (echocardiography); 10. Heart failure (echocardiography); 11. Cerebrovascular accident; 12. Ruptured aortic aneurysm; 13. Aortic volume (MRI); 14. LVEDV, LVESV, EF, CO (MRI); 15. Pulse wave velocity through the thoracic aorta (MRI); 16. Extent of LV fibrosis (%) (MRI); 17. The number of deaths.

—

Contacts

Public ContactB.J. Bouma

Academic Medical Centre (AMC) Department of cardiology Room F3 – 115

b.j.bouma@amc.uva.nl+31 (0)20 5666051

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)