Investigating RNA profiles in heart failure and aortic stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the global transcriptome to identify the expression profiles of messenger RNAs (mRNAs), long noncoding RNAs (lncRNAs), and micro RNAs (miRNAs) in patients with heart failure and aortic stenosis. Researchers will collect plasma and cardiac tissue specimens from participants, including those with both end-stage and non-end-stage heart failure, as well as patients undergoing aortic valve replacement. The study seeks to clarify the role of these RNA molecules in cardiac disease pathogenesis and their potential as biomarkers by comparing affected individuals to those without cardiovascular diseases.

Why it matters

Who can join: the full rules

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

Where it's running

• Irccs Policlinico San Donato
  San Donato Milanese, Milan, Italy Recruiting
• Ospedale San Raffaele
  Milan, Italy Recruiting

Study contacts

• Principal investigator: Fabio Martelli, Dr — IRCCS Policlinico S. Donato
• Study coordinator: Fabio Martelli, Dr
• Email: fabio.martelli@grupposandonato.it
• Phone: +39 02 26437762

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.