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Clinical Trials in Italy / NCT03268135
Recruiting Observational

Heart Failure and Aortic Stenosis Transcriptome

NCT03268135 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Policlinico S. Donato
Phase
Observational
Started
2016-05-30
Last updated
2025-04-30

Condition(s) studied

Heart FailureAortic Stenosis

Investigational drug(s) / intervention(s)

measurement of RNAs

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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
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

Primary outcome measure(s)

  • Cardiac tissutal mRNAs signatures — 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
  • Cardiac tissutal miRNAs signatures — 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
  • Cardiac tissutal lncRNAs signatures — 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

Trial sites (2)

FacilityCityRegionStatus
Irccs Policlinico San Donato San Donato Milanese Milan Recruiting
Ospedale San Raffaele Milan Italy Recruiting

More IRCCS Policlinico S. Donato trials in Italy

Novel Risk Prediction Approaches for the Primary Prevention of Cardiovascular Diseases in Italy: the CVRISK-IT Trial (CVRISK-IT) Recruiting
Multivariate Approach to the Numerical Assessment of Cortical - Autonomic - VAscular Dynamic Interplay Recruiting
RNA as Prognostic Biomarkers in Patients With Acute Coronary Syndrome Recruiting
OUTcomes Evaluation of Current Therapeutic STrategies for Severe Aortic Valve steNosis anD the agING Population in ITALY Recruiting
Strength Tracking From Wall Tichness Over Aortic Biomechanics (STORM) Recruiting

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Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03268135 on ClinicalTrials.gov ↗ ← All trials in Italy