Prospective Randomized Trial of the Effects of Rosuvastatin on the Progression of Stenosis in Adult Patients with Congenital Aortic Stenosis.

• Conditions: Aortic valve stenosis, congenital heart defects

• Registration Number: NL-OMON24714
• Lead Sponsor: Erasmus Medical Center, Rotterdam, Department of Cardiology

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

1. Valvular congenital aortic stenosis with a maximum aortic jet velocity > 2.5 m/s;
2. Age 18-45 years.

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. Hhistory 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 (creatinin > 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 ciclosporin.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression of aortic stenosis measured by transthoracic echocardiography.

Secondary Outcome Measures

Name	Time	Method
Progression of aortic dilatation and development of left ventricular hypertrophy measured by MRI and transthoracic echocardiography.