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NCT03268135Recruiting

Heart Failure and Aortic Stenosis Transcriptome

Study of the Transcriptomic Alterations in Heart Failure and Aortic Stenosis

Source: ClinicalTrials.gov · Last updated 30 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
500 (estimated)
First submitted
17 Jul 2017
Start date
30 May 2016
Primary completion date
31 Dec 2024
Lead sponsor
IRCCS Policlinico S. Donato
NCT number
NCT03268135

What you commit to

  • Study type: Observational
  • Planned participants: 500
  • From 30 May 2016 to the primary completion date, 31 Dec 2024
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Lab values

  • 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

Who the study is looking for

  • 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

Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ospedale San Raffaele
Coordinator of this site? Confirm its status
MilanItalyRecruiting
IRCCS Policlinico San Donato
Coordinator of this site? Confirm its status
San Donato MilaneseItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.