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

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • Murcia, Spain, 30120
        • Hospital Clínico Universitario Virgen de la Arrixaca
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Sevilla, Spain, 41071
        • Hospital Universitario Virgen De La Macarena
      • Valladolid, Spain, 47005
        • Hospital Clinico Universitario de Valladolid
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36200
        • Hospital Universitario de Vigo
    • Tarragona
      • Reus, Tarragona, Spain, 43204
        • Hospital Universitari Sant Joan de Reus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atorvastatin
Oral administration Atorvastatin 20 mg per day
Oral administration atorvastatin 20 mg per day
Placebo Comparator: Control
Oral administration of Placebo
Oral administration placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the diameter of ascending aorta by CT (Computed Tomography).
Time Frame: 3 years
Determination of the progression of ascending aortic dilation assessed by measuring the change of the diameter of ascending aorta by CT (Computed Tomography).The change of the aortic diameter will be defined by the major difference between the measurements taken in the aortic root and ascending aorta in the initial and final study.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the final maximum diameter of the aortic root and the basal measured by CT.
Time Frame: 3 years
Difference between the final maximum diameter of the aortic root and the basal measured by CT.
3 years
Change of the final maximum diameter of the tubular ascending aorta and the basal measured by CT.
Time Frame: 3 years
Difference between the final maximum diameter of the tubular ascending aorta and the basal measured by CT.
3 years
Change of the final area of the aortic root and the basal measured by CT.
Time Frame: 3 years
Difference between the final area of the aortic root and the basal measured by CT.
3 years
Change of the the final area of ascending aorta and the basal measured by CT.
Time Frame: 3 years
Difference between the final area of ascending aorta and the basal measured by CT.
3 years
Change of the valve Agatston final score and the basal assessed by CT.
Time Frame: 3 years
Difference between the valve Agatston final score and the basal assessed by CT.
3 years
Change of the final planimetry area of the aortic valve and the basal measured by CT.
Time Frame: 3 years
Difference between the final planimetry area of the aortic valve and the basal measured by CT.
3 years
Change of the transvalvular pressure gradient of the aortic valve
Time Frame: 3 years
Difference of transvalvular pressure gradient of the aortic valve
3 years
Change of aortic regurgitation jet width basal and final.
Time Frame: 3 years
Difference of aortic regurgitation jet width basal and final.
3 years
Change of the maximum aortic velocity
Time Frame: 3 years
Change of the maximum aortic velocity
3 years
Change of aortic valve area
Time Frame: 3 years
Change of aortic valve area by continuity equation basal and final
3 years
Ocurrence of Serious Adverse Clinical Events leading to hospitalization and death
Time Frame: 3 years
Serious Adverse Clinical Events: Aortic dissection, aortic rupture or need for aortic surgery, cardiovascular death, death of any cause. Combined endpoint of death, aortic dissection or need for aortic or valve surgery.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Arturo Evangelista-Masip, MD, PhD, Professor, Hospital Universitari Vall d'Hebron, Vall d'Hebron Institut de Recerca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

February 6, 2016

First Posted (Estimate)

February 10, 2016

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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