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RecruitingNCT03268135RNA-HF-ASUpdated Apr 30, 2025

Heart Failure and Aortic Stenosis Transcriptome

An observational study in Heart Failure and Aortic Stenosis, sponsored by IRCCS Policlinico S. Donato. Recruiting at 2 sites in Italy. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-30.

Sponsored by IRCCS Policlinico S. Donato · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
500
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Heart Failure
  • Aortic Stenosis

Keywords

  • miRNA
  • lncRNAs
  • transcriptome
  • heart failure
  • aortic stenosis
  • biomarkers
03

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Cardiac surgery patients

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

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
04

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Non end-stage heart failure

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

    Diagnostic Test: measurement of RNAs

  • End-stage heart failure

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

    Diagnostic Test: measurement of RNAs

  • Aortic Stenosis

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

    Diagnostic Test: measurement of RNAs

  • Controls

    Measurement of RNAs in individuals not affected by cardiovascular diseases

    Diagnostic Test: measurement of RNAs

Interventions

  • Diagnostic testmeasurement of RNAs
05

What researchers measure

Primary outcomes

  1. Cardiac tissutal mRNAs signatures

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

    Time frame: from Year 1 to Year 3

  2. Cardiac tissutal miRNAs signatures

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

    Time frame: from Year 1 to Year 3

  3. Cardiac tissutal lncRNAs signatures

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

    Time frame: from Year 1 to Year 3

Secondary outcomes

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

    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

    Time frame: from Year 3 to Year 5

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

    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

    Time frame: from Year 3 to Year 5

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

    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

    Time frame: from Year 3 to Year 5

06

Study locations

2 of 2 sites recruiting
  • Irccs Policlinico San Donato
    San Donato Milanese, Milan 20097, Italy
    • FABIO MARTELLI, PhD · Contact · fabio.martelli@grupposandonato.it · 0252774683
    • LORENZO MENICANTI, MD · Sub investigator
    • SIMONA GRECO, PhD · Sub investigator
    • SERENELLA CASTELVECCHIO, MD · Sub investigator
    Recruiting
  • Ospedale San Raffaele
    Milano, 20132, Italy
    • Michele De Bonis, MD, PhD · Contact · debonis.michele@hsr.it
    • MICHELE DE BONIS, MD FESC FAHA · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03268135
Lead sponsor
IRCCS Policlinico S. Donato
Collaborators
Ospedale San Raffaele
Responsible party
Fabio Martelli (Dr, PhD, Molecular Cardiology Laboratory Director, IRCCS Policlinico S. Donato) — Principal investigator
First posted
Aug 31, 2017
Start date
May 30, 2016
Primary completion
Dec 31, 2024
Completion
Dec 31, 2027 (estimated)
Last update
Apr 30, 2025

Study contacts

Fabio Martelli, Dr
Contact
fabio.martelli@grupposandonato.it
+39 02 26437762
Fabio Martelli, Dr
principal investigator · IRCCS Policlinico S. Donato

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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