Heart Failure and Aortic Stenosis Transcriptome

NCT ID: NCT03268135

Last Updated: 2025-04-30

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

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-30

Study Completion Date

2027-12-31

Brief Summary

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This study is aimed to investigate the global transcriptome in order to determine the expression profile of messenger RNAs (mRNAs), as well as long noncoding- (lncRNAs) and micro noncoding-RNAs (miRNAs) in heart failure (HF) and in aortic stenosis (AS). The aim is to clarify their role in cardiac disease pathogenesis, as well as their potential as biomarkers. To this purpose, both tissue and blood specimens will be collected and patients will be compared to individuals not affected by cardiovascular diseases.

Detailed Description

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The investigators will collect plasma and cardiac tissue specimens from consenting subjects. The investigators will evaluate the expression of mRNAs, miRNAs and lncRNAs in patients affected by both end-stage and not end-stage HF as well as in patients affected by aortic stenosis and undergoing valve replacement and requiring cardiac myectomy. The tissue dysregulated RNAs will be next measured in plasma samples in order to clarify their potential as biomarkers.

Conditions

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Heart Failure Aortic Stenosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Non end-stage heart failure

Measurement of RNAs in non end-stage heart failure patients undergoing to left ventricle reconstruction

measurement of RNAs

Intervention Type DIAGNOSTIC_TEST

End-stage heart failure

Measurement of RNAs in end-stage heart failure patients undergoing to left ventricular assisted device (LVAD)

measurement of RNAs

Intervention Type DIAGNOSTIC_TEST

Aortic Stenosis

Measurement of RNAs in patients affected by cardiac hypertrophy leading to aortic stenosis and requiring cardiac myectomy

measurement of RNAs

Intervention Type DIAGNOSTIC_TEST

Controls

Measurement of RNAs in individuals not affected by cardiovascular diseases

measurement of RNAs

Intervention Type DIAGNOSTIC_TEST

Interventions

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measurement of RNAs

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Non end-stage heart failure

* left ventricle restoration surgery (SVR)
* End Systolic Volume Index (ESVI) \>35 ml/m2
* Ejection Fraction (EF)\<40%
* previous transmural anterior myocardial infarction (MI)
* age: 40-75
2. End-stage heart failure

* left ventricle assisted device (LVAD) surgery
* age: 40-75
* Ejection Fraction (EF) \<25%
* End Systolic Volume Index (ESVI)≥60 ml/m2
3. Aortic Stenosis

* aortic valve replacement
* intracardial pressure difference \>40 mmHg
* septal diameter ≥1.3 cm

Exclusion Criteria

1. Non end-stage heart failure

* End Systolic Volume Index (ESVI)\<35 ml/m2
* Ejection Fraction (EF)\>40%
* Time from MI unknown
* Pregnancy
* Other genetic diseases
* Neoplasms
* Collagenopathies
* Chemo/radiotherapy
* Prolonged use of corticosteroids
* Infections
* Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive
2. End-stage heart failure

* EF\>25%
* Time from MI unknown
* Pregnancy
* Other genetic diseases
* Neoplasms
* Collagenopathies
* Chemo/radiotherapy
* Prolonged use of corticosteroids
* Infections
* Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive
3. Aortic Stenosis

* coronaropathies
* Pregnancy
* Other genetic diseases
* Neoplasms
* Collagenopathies
* Chemo/radiotherapy
* Prolonged use of corticosteroids
* Infections
* Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale San Raffaele

OTHER

Sponsor Role collaborator

IRCCS Policlinico S. Donato

OTHER

Sponsor Role lead

Responsible Party

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Fabio Martelli

Dr, PhD, Molecular Cardiology Laboratory Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fabio Martelli, Dr

Role: PRINCIPAL_INVESTIGATOR

IRCCS Policlinico S. Donato

Locations

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Irccs Policlinico San Donato

San Donato Milanese, Milan, Italy

Site Status RECRUITING

Ospedale San Raffaele

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Fabio Martelli, Dr

Role: CONTACT

+39 02 26437762

Facility Contacts

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FABIO MARTELLI, PhD

Role: primary

0252774683

Michele De Bonis, MD, PhD

Role: primary

Other Identifiers

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RNA-HF-AS

Identifier Type: -

Identifier Source: org_study_id

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