Assessment of atorvastatin efficacy on the progression of aortic dilatation and valvular degeneration in patients with bicuspid aortic valve (BICATOR)

• Conditions: Valve Disease; MedDRA version: 18.1Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-001808-57-ES
• Lead Sponsor: Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-30
• Last Update Posted: 22 December 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Patients ? 18 years with bicuspid aortic valve confirmed by TTE (in case of doubt the use of other imaging techniques require: TEE or CT to confirm the diagnosis).
-Disfunción Valve only moderate: in case of aortic stenosis with average <20 mmHg gradient and in case of aortic insufficiency with contracta <5 vein or jet width <7.
-Aortic valve not show more light spots of calcification transthoracic study.
-Diámetros Level aortic ascending aorta (sinus of Valsalva or tubular ascending aorta) ? 21mm / m2 but not reach 50 mm.
-To Written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

- Patients <18 years
- Patients with uncontrolled hypertension and a history or risk of diabetes mellitus
- Patients who are treated with statins or other lipid-lowering drug or have it as indication for clinical practice guidelines.
- History of heart surgery or any segment of the aorta
- A history of aortic dissection and / or aortic coarctation
- Functional Class III-IV
- History or presence of hepatic impairment (serum transaminases> 2times the upper limit of normal by each laboratory), renal (creatinine clearance <30 ml / min or creatinine> 2.5mg / dl), myopathy myopathy or creatine kinase levels> 5 times the ULN, and other gastrointestinal diseases, hematologic, endocrine or any other situation which in the opinion of the researcher may affect the assessment of study treatment
- Hypersensitivity or intolerance to any component of the study drug or to intravenous contrast used in the TC
- Pregnancy, lactation or gestational desire during the test period. In all women of childbearing age, a result of negative gonadotropin be required in the pregnancy test for entry into the study.
- Ongoing Participation in another clinical trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified