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

NCT ID: NCT02679261

Last Updated: 2021-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2021-02-28

Brief 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.

Detailed Description

BICATOR is a multicentre (8 centres), randomised, double-blind and placebo-controlled clinical trial aimed at evaluating the effect of atorvastatin in reducing progression of aortic dilation in patients with BAV. The primary outcome is to determine whether atorvastatin is effective in reducing aortic dilation in BAV and secondary outcome is to define if atorvastatin treatment slows the progression of aortic valve degeneration (valve calcification) in a 3 year follow-up period. 220 patients will be included (110 atorvastatin - 110 placebo).

Conditions

Bicuspid Aortic Valve

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Atorvastatin

Oral administration Atorvastatin 20 mg per day

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: DRUG

Oral administration atorvastatin 20 mg per day

Control

Oral administration of Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral administration placebo

Interventions

Atorvastatin

Oral administration atorvastatin 20 mg per day

Intervention Type: DRUG

Placebo

Oral administration placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arturo Evangelista-Masip, MD, PhD, Professor

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Vall d'Hebron, Vall d'Hebron Institut de Recerca

Locations

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitario de Vigo

Vigo, Pontevedra, Spain

Hospital Universitari Sant Joan de Reus

Reus, Tarragona, Spain

Hospital Vall d'Hebron

Barcelona, , Spain

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, , Spain

Hospital Universitario Virgen de la Macarena

Seville, , Spain

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Countries

Spain

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Other Identifiers

BICATOR

Identifier Type: -

Identifier Source: org_study_id