Contact information
Type
Scientific
Primary contact
Dr J W Roos-Hesselink
ORCID ID
Contact details
Erasmus Medical Center
Department of Cardiology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 4632432
j.roos@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PROCAS
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Progression of aortic stenosis measured by transthoracic echocardiography.
Secondary outcome measures
Progression of aortic dilatation and development of left ventricular hypertrophy measured by MRI and transthoracic echocardiography.
Overall trial start date
01/11/2005
Overall trial end date
01/11/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Valvular congenital aortic stenosis with a maximum aortic jet velocity >2.5 m/s
2. Age 18-45 years
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
180
Participant 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
Recruitment start date
01/11/2005
Recruitment end date
01/11/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Center
Rotterdam
3000 CA
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
Erasmus Medical Center, Department of Cardiology (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary