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NCT Number: NCT03268135

Heart Failure and Aortic Stenosis Transcriptome

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.

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Key information

Conditions

Heart Failure Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Irccs Policlinico San Donato, San Donato Milanese, Milan, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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
  • Aortic Stenosis
  • aortic valve replacement
  • intracardial pressure difference >40 mmHg
  • septal diameter ≥1.3 cm

Exclusion criteria

  • 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
  • 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
  • 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

Treatment and study plan

measurement of RNAs

Diagnostic Test

Primary outcomes

  1. Cardiac tissutal mRNAs signatures

    Time frame: from Year 1 to Year 3

    The mRNAs cardiac tissutal signatures of non- and end-stage heart failure patients and of aortic stenosis patients compared to controls

  2. Cardiac tissutal miRNAs signatures

    Time frame: from Year 1 to Year 3

    The miRNAs cardiac tissutal signatures of non- and end-stage heart failure patients and of aortic stenosis patients compared to controls

  3. Cardiac tissutal lncRNAs signatures

    Time frame: from Year 1 to Year 3

    The lncRNAs cardiac tissutal signatures of non- and end-stage heart failure patients and of aortic stenosis patients compared to controls

Secondary outcomes

  1. Non end-stage, end-stage heart failure, aortic stenosis mRNAs signatures in plasmas

    Time frame: from Year 3 to Year 5

    The 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

  2. Non end-stage, end-stage heart failure, aortic stenosis miRNAs signatures in plasmas

    Time frame: from Year 3 to Year 5

    The 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

  3. Non end-stage, end-stage heart failure, aortic stenosis lncRNAs signatures in plasmas

    Time frame: from Year 3 to Year 5

    The 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

Study contacts

Contact information is provided by the study sponsor or research team.

Fabio Martelli, Dr

CONTACT

[email protected]

+39 02 26437762

Sponsors and collaborators

Lead sponsor

IRCCS Policlinico S. Donato

Other

Collaborators

  • Ospedale San Raffaele

Registry information

Official study title

Study of the Transcriptomic Alterations in Heart Failure and Aortic Stenosis

Acronym: RNA-HF-AS

Important dates

Study start
2016
Primary completion
2024
Study completion
2027
First posted
Aug 31, 2017
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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