Evaluating the Effectiveness of Atorvastatin on the Progression of Aortic Dilatation and Valvular… (NCT02679261) | Clinical Trial Compass
CompletedPhase 3
Evaluating the Effectiveness of Atorvastatin on the Progression of Aortic Dilatation and Valvular Degeneration in Patients With Bicuspid Aortic Valve
Spain220 participantsStarted 2016-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients ≥ 18 years old with BAV confirmed by transthoracic echocardiography (in case of doubts other techniques will be required: transesophageal echocardiography or CT to confirm diagnosis).
* Valve dysfunction only moderate: in case of aortic stenosis with average gradient \< 30 mmHg and in case of aortic regurgitation a vena contracta \< 7 mm or a jet with \< 10 mm.
* Aortic valve not show severe calcification by transthoracic echocardiography.
* Ascending aortic diameter (Valsalva sinus or tubular ascending aorta) ≤ 50 mm.
* The patient must give the consent form signed.
Exclusion Criteria:
* Patients younger than 18.
* Patients with uncontrolled hypertension and a history or risk of diabetes mellitus.
* Patients who receive statins treatment or other lipid lowering drug or if they have indication to be treated according to the current clinical practice guidelines.
* Previous cardiac surgery or any surgery of other segments of the aorta.
* Previous aortic dissection and/or aortic coarctation.
* NYHA functional class III or IV.
* Presence or antecedent of liver failure (transaminase \> 2 fold the superior limit of normal levels according to local laboratory), renal failure (creatinine clearance \< 30ml/min or creatinine \> 2.5mg/dl), myopathy or creatine kinase levels \> 5 fold the superior limit of normality, or other gastrointestinal, hematologic or endocrine diseases or any other situation that according to the investigator criteria could affec…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of the diameter of ascending aorta by CT (Computed Tomography).
Timeframe: 3 years
Trial details
NCT IDNCT02679261
SponsorHospital Universitari Vall d'Hebron Research Institute