Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2025-12-24 @ 11:45 AM
NCT ID:
NCT02679261
Eligibility Criteria:
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 affect the study treatment evaluation.
* Hypersensitivity, intolerance or contraindication to any component of the study drug or to the contrast used in CT.
* Pregnancy, breastfeeding or desire for pregnancy during the study period. A negative pregnancy test (negative gonadotropin) will be required in all fertile women to participate in the study.
* Participation in another drug study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02679261
Study Brief:
Protocol Section:
NCT02679261