Omics in Valvular Disease

NCT ID: NCT05768594

Last Updated: 2023-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-15

Study Completion Date

2023-12-13

Brief Summary

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The aim of our study is to investigate the effects of impaired left ventricular remodeling on the short- and long-term prognosis in AS partecipants undergoing extracorporeal circulation during valve repair surgery and in partecipants undergoing implantation transcatheter. For the achievement of these purposes, markers obtained from will be considered cardiovascular imaging methods, such as color Doppler echocardiography and isolated biomarkers from peripheral blood and heart tissue.

Detailed Description

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Participation in this study includes, following enrollment, a visit of follow up (6/12 months) on the occasion of a concomitant medical check-up scheduled according to normal clinical practice. During these visits venous and contextual blood samples will be taken echocardiographic examination for re-evaluation of ejection fraction, as per normal practice clinic. The only variant will be the withdrawal of an additional aliquot of blood during the sampling standard blood.

All enrolled partecipants will undergo the optimal medical treatment provided by current and more recent guidelines for the treatment of heart valve disease. Joining this study will not result any modification of the current therapy, which will be established by the attending physician according to the correct one clinical practice.

Conditions

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Stenosis, Aortic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with aortic stenosis, surgical valve replacement

15 patients undergoing surgical valve replacement (SAVR)

Blood sample

Intervention Type OTHER

After blood sampling, patients will undergo a Color Doppler Echocardiogram, a non-invasive method

Patients with aortic stenosis, undergoing transcatheter aortic valve implantation

15 patients undergoing transcatheter aortic valve replacement (TAVR)

Blood sample

Intervention Type OTHER

After blood sampling, patients will undergo a Color Doppler Echocardiogram, a non-invasive method

Interventions

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Blood sample

After blood sampling, patients will undergo a Color Doppler Echocardiogram, a non-invasive method

Intervention Type OTHER

Other Intervention Names

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Color Doppler echocardiogram

Eligibility Criteria

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Inclusion Criteria

-30 patients with a diagnosis of severe aortic stenosis and preserved ejection fraction to echocardiographic evaluation

Exclusion Criteria

* inflammatory;
* infectious diseases;
* neoplasms;
* ailments immunological or haematological;
* treatment with anti-inflammatory drugs except aspirin a low dose (75-160 mg);
* age \> 85 years;
* advanced chronic kidney disease with filtrate glomerular heart rate (eGFR) estimated by MDRD equation \<30 ml/min./1.73 m2.
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Liuzzo Giovanna

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fondazione Policlinico Gemelli

Roma, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Liuzzo LG Giovanna

Role: CONTACT

+39 06/30154187

Daniela DP Pedicino

Role: CONTACT

+39 06/30154187

Facility Contacts

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Giovanna GL Liuzzo

Role: primary

+39 06/30154187

Other Identifiers

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2821

Identifier Type: -

Identifier Source: org_study_id

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