Prospective Randomized Trial of the Effects of Rosuvastatin on the Progression of Stenosis in Adult Patients with Congenital Aortic Stenosis
| ISRCTN | ISRCTN56552248 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56552248 |
| Protocol serial number | N/A |
| Sponsor | Erasmus Medical Center, Department of Cardiology (Netherlands) |
| Funder | Erasmus Medical Center, Department of Cardiology (Netherlands) |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 07/08/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J W Roos-Hesselink
Scientific
Scientific
Erasmus Medical Center
Department of Cardiology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
| Phone | +31 (0)10 4632432 |
|---|---|
| j.roos@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | PROCAS |
| Study objectives | The primary objective of this study is to determine whether treatment with statins reduce the progression of aortic stenosis in young adult patients with congenital aortic stenosis. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Aortic valve stenosis, congenital heart defects |
| Intervention | After completion of all baseline investigations (echocardiography, MRI and venous blood collection) patients will be randomly assigned to the statin group or to the placebo group. Patients in the statin group will receive 10 mg rosuvastatin per day. The treatment should be continued until the study end (36 months). Follow up investigations will be performed after 12 and 24 months. After 36 months the final investigations will be performed. The MRI measurements will only be repeated at 36 months. |
| Intervention type | Other |
| Primary outcome measure(s) |
Progression of aortic stenosis measured by transthoracic echocardiography. |
| Key secondary outcome measure(s) |
Progression of aortic dilatation and development of left ventricular hypertrophy measured by MRI and transthoracic echocardiography. |
| Completion date | 01/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | All |
| Target sample size at registration | 180 |
| Key inclusion criteria | 1. Valvular congenital aortic stenosis with a maximum aortic jet velocity >2.5 m/s 2. Age 18-45 years |
| Key exclusion criteria | 1. Use of statins or other study medication 2. Subvalvular or supravalvular aortic stenosis 3. Aortic regurgitation >2+ 4. Malignancy within last 2 years 5. Aortic valve replacement in past 6. Rheumatic fever in past 7. Significant concomitant mitral valve disease (MR >2+ or MVA <1.5 cm2) 8. History of HMG-CoA reductase inhibitor hypersensitivity 9. Active liver disease 10. Muscular/neuromuscular disease 11. CPK >3 x upper limit of normal (>600 U/l) 12. Renal impairment (creatinine >200 umol/l) 13. Women contemplating pregnancy within next 5 years 14. Pregnant/breast-feeding women 15. Women of childbearing potential not using appropriate contraception 16. Use of cyclosporine |
| Date of first enrolment | 01/11/2005 |
| Date of final enrolment | 01/11/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3000 CA
Netherlands
3000 CA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
