Condition category
Circulatory System
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
07/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Erasmus Medical Center, Department of Cardiology (Netherlands)

Sponsor details

P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes