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Heart Failure and Aortic Stenosis Transcriptome

Study of the Transcriptomic Alterations in Heart Failure and Aortic Stenosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03268135
Acronym
RNA-HF-AS
Enrollment
500
Registered
2017-08-31
Start date
2016-05-30
Completion date
2027-12-31
Last updated
2025-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis, Heart Failure

Keywords

miRNA, lncRNAs, transcriptome, heart failure, aortic stenosis, biomarkers

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTmeasurement of RNAs

Sponsors

Ospedale San Raffaele
CollaboratorOTHER
IRCCS Policlinico S. Donato
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiac tissutal lncRNAs signaturesfrom Year 1 to Year 3The lncRNAs cardiac tissutal signatures of non- and end-stage heart failure patients and of aortic stenosis patients compared to controls
Cardiac tissutal mRNAs signaturesfrom Year 1 to Year 3The mRNAs cardiac tissutal signatures of non- and end-stage heart failure patients and of aortic stenosis patients compared to controls
Cardiac tissutal miRNAs signaturesfrom Year 1 to Year 3The miRNAs cardiac tissutal signatures of non- and end-stage heart failure patients and of aortic stenosis patients compared to controls

Secondary

MeasureTime frameDescription
Non end-stage, end-stage heart failure, aortic stenosis mRNAs signatures in plasmasfrom Year 3 to Year 5The mRNAs dysregulated in cardiac tissues will be measured in blood plasma samples of non- and end-stage heart failure patients and of aortic stenosis patients compared to controls
Non end-stage, end-stage heart failure, aortic stenosis miRNAs signatures in plasmasfrom Year 3 to Year 5The miRNAs dysregulated in cardiac tissues will be measured in blood plasma samples of non- and end-stage heart failure patients and of aortic stenosis patients compared to controls
Non end-stage, end-stage heart failure, aortic stenosis lncRNAs signatures in plasmasfrom Year 3 to Year 5The lncRNAs dysregulated in cardiac tissues will be measured in blood plasma samples of non- and end-stage heart failure patients and of aortic stenosis patients compared to controls

Countries

Italy

Contacts

Primary ContactFabio Martelli, Dr
fabio.martelli@grupposandonato.it+39 02 26437762

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026