Heart Failure and Aortic Stenosis Transcriptome (RNA-HF-AS)

San Donato Group (GSD)

Status: Enrolling

Conditions: Heart Failure; Aortic Stenosis

Treatments: Diagnostic Test: measurement of RNAs

Study type: Observational

Funder types: Other

Identifiers

NCT03268135

RNA-HF-AS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 4 patient groups

Non end-stage heart failure

Description:

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

Treatment:

Diagnostic Test: measurement of RNAs

End-stage heart failure

Description:

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

Treatment:

Diagnostic Test: measurement of RNAs

Aortic Stenosis

Description:

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

Treatment:

Diagnostic Test: measurement of RNAs

Controls

Description:

Measurement of RNAs in individuals not affected by cardiovascular diseases

Treatment:

Diagnostic Test: measurement of RNAs