drugset / Trial / NCT02679261

Evaluating the Effectiveness of Atorvastatin on the Progression of Aortic Dilatation and Valvular Degeneration in Patients With Bicuspid Aortic Valve

NCT02679261 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Bicuspid Aortic Valve (BAV) is the most common congenital heart disease affecting 1-2% of the population. The aortic dilation and aortic valve degeneration are common complications in patients with BAV. Statins have shown a reduction in the expression of metalloproteinases of the extracellular matrix observed in aortic aneurisms. Several retrospective studies have suggested the benefit of the statins to reduce aortic dilation in patients with BAV. Moreover, although statins did not show to be useful in the progression of aortic stenosis, different studies have suggested a higher profit when the valve affection is not severe. The objective of this study is to determine whether atorvastatin is effective at reducing the progression of aortic dilation in patients with BAV.

Timeline

Start
2016-06
Primary completion
2021-02
Completion
2021-02

Outcome

Missed primary endpoint

paper The maximum ascending aorta diameter increased with no differences between groups: PMID 38804148 ↗

paper Similarly, no significant differences were found for the progression of the aortic valve calcium score (P=0.167) or valvular dysfunction. PMID 38804148 ↗

paper atorvastatin treatment was not effective in reducing the progression of ascending aorta dilation and aortic valve calcification during 3 years of treatment PMID 38804148 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 20 mg Oral

Indications