Valve Disease MedDRA version: 18.1 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Atorvastatin 20 mg
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: - Patients 2times the upper limit of normal by each laboratory), renal (creatinine clearance 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To determine whether treatment with atorvastatin is effective in reducing the progression of aortic dilatation in patients with bicuspid aortic valve.;Secondary Objective: -To Define whether atorvastatin treatment slows the progression of valvular degeneration (valvular calcification) - To Define whether treatment with atorvastatin reduces clinical events during 3 years of follow-up.;Primary end point(s): Determination of the progression of aortic dilatation of the ascending aorta by measuring the change in diameter of the ascending aorta by CT in three years follow-up. The change in aortic diameter is defined by most of the differences between the measurements taken at the level of the aortic root and ascending aorta at baseline and end of study.;Timepoint(s) of evaluation of this end point: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 3 years;Timepoint(s) of evaluation of this end point: 3 years | — |
Countries
Spain
Contacts
Public ContactArtur Evangelista Masip
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
Outcome results
None listed