Status:
RECRUITING
Heart Failure and Aortic Stenosis Transcriptome
Lead Sponsor:
IRCCS Policlinico S. Donato
Collaborating Sponsors:
Ospedale San Raffaele
Conditions:
Heart Failure
Aortic Stenosis
Eligibility:
All Genders
40-75 years
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 (miRNA...
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 en...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
May 30 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03268135
Start Date
May 30 2016
End Date
December 31 2027
Last Update
April 30 2025
Active Locations (2)
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1
Irccs Policlinico San Donato
San Donato Milanese, Milan, Italy, 20097
2
Ospedale San Raffaele
Milan, Italy, 20132