Aortic Stenosis, Heart Failure
Conditions
Keywords
miRNA, lncRNAs, transcriptome, heart failure, aortic stenosis, biomarkers
Brief 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.
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.
Interventions
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non end-stage, end-stage heart failure, aortic stenosis mRNAs signatures in plasmas | 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 |
| Non end-stage, end-stage heart failure, aortic stenosis miRNAs signatures in plasmas | 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 |
| Non end-stage, end-stage heart failure, aortic stenosis lncRNAs signatures in plasmas | 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 |
Countries
Italy