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

Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)0 个研究点开始时间: 2015年10月30日最近更新: 2015年12月22日

适应症

试验速览

暂无简介。

•-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

•- 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

发起方

Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)