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
Secondary identifying numbers	N/A

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

Dr J W Roos-Hesselink
Scientific

Erasmus Medical Center
Department of Cardiology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Phone	+31 (0)10 4632432
Email	j.roos@erasmusmc.nl

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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	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 study start date	01/11/2005
Completion date	01/11/2009

Participant type(s)	Patient
Age group	Not Specified
Lower age limit	18 Years
Upper age limit	45 Years
Sex	Both
Target number of participants	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

Erasmus Medical Center

Rotterdam
3000 CA
Netherlands

Erasmus Medical Center, Department of Cardiology (Netherlands)
Hospital/treatment centre

P.O. Box 2040
Rotterdam
3000 CA
Netherlands

"ROR"	https://ror.org/018906e22

Hospital/treatment centre

Erasmus Medical Center, Department of Cardiology (Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan