Hjertesvikt og aortastenose transkriptom (RNA-HF-AS)
Studie av transkriptomiske endringer i hjertesvikt og aortastenose
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Fabio Martelli, Dr
- Telefonnummer: +39 02 26437762
- E-post: fabio.martelli@grupposandonato.it
Studiesteder
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Milan, Italia, 20132
- Rekruttering
- Ospedale San Raffaele
-
Ta kontakt med:
- Michele De Bonis, MD, PhD
- E-post: debonis.michele@hsr.it
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Hovedetterforsker:
- MICHELE DE BONIS, MD FESC FAHA
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Milan
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San Donato Milanese, Milan, Italia, 20097
- Rekruttering
- Irccs Policlinico San Donato
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Ta kontakt med:
- FABIO MARTELLI, PhD
- Telefonnummer: 0252774683
- E-post: fabio.martelli@grupposandonato.it
-
Underetterforsker:
- SIMONA GRECO, PhD
-
Underetterforsker:
- LORENZO MENICANTI, MD
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Underetterforsker:
- SERENELLA CASTELVECCHIO, MD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Cardiac surgery patients
Beskrivelse
Inclusion Criteria:
-
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
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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 Criteria:
-
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: CASE_CONTROL
- Tidsperspektiver: RETROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Non end-stage heart failure
Measurement of RNAs in non end-stage heart failure patients undergoing to left ventricle reconstruction |
|
|
End-stage heart failure
Measurement of RNAs in end-stage heart failure patients undergoing to left ventricular assisted device (LVAD) |
|
|
Aortic Stenosis
Measurement of RNAs in patients affected by cardiac hypertrophy leading to aortic stenosis and requiring cardiac myectomy |
|
|
Controls
Measurement of RNAs in individuals not affected by cardiovascular diseases |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cardiac tissutal mRNAs signatures
Tidsramme: 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 |
from Year 1 to Year 3
|
|
Cardiac tissutal miRNAs signatures
Tidsramme: 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 |
from Year 1 to Year 3
|
|
Cardiac tissutal lncRNAs signatures
Tidsramme: 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 |
from Year 1 to Year 3
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Non end-stage, end-stage heart failure, aortic stenosis mRNAs signatures in plasmas
Tidsramme: 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 |
from Year 3 to Year 5
|
|
Non end-stage, end-stage heart failure, aortic stenosis miRNAs signatures in plasmas
Tidsramme: 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 |
from Year 3 to Year 5
|
|
Non end-stage, end-stage heart failure, aortic stenosis lncRNAs signatures in plasmas
Tidsramme: 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 |
from Year 3 to Year 5
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Fabio Martelli, Dr, IRCCS Policlinico S. Donato
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RNA-HF-AS
Plan for individuelle deltakerdata (IPD)
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