Hjärtsvikt och aortastenos transkriptom (RNA-HF-AS)
Studie av transkriptomiska förändringar vid hjärtsvikt och aortastenos
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Fabio Martelli, Dr
- Telefonnummer: +39 02 26437762
- E-post: fabio.martelli@grupposandonato.it
Studieorter
-
-
-
Milan, Italien, 20132
- Rekrytering
- Ospedale San Raffaele
-
Kontakt:
- Michele De Bonis, MD, PhD
- E-post: debonis.michele@hsr.it
-
Huvudutredare:
- MICHELE DE BONIS, MD FESC FAHA
-
-
Milan
-
San Donato Milanese, Milan, Italien, 20097
- Rekrytering
- Irccs Policlinico San Donato
-
Kontakt:
- FABIO MARTELLI, PhD
- Telefonnummer: 0252774683
- E-post: fabio.martelli@grupposandonato.it
-
Underutredare:
- SIMONA GRECO, PhD
-
Underutredare:
- LORENZO MENICANTI, MD
-
Underutredare:
- SERENELLA CASTELVECCHIO, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Cardiac surgery patients
Beskrivning
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
-
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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: CASE_CONTROL
- Tidsperspektiv: RETROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cardiac tissutal mRNAs signatures
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Non end-stage, end-stage heart failure, aortic stenosis mRNAs signatures in plasmas
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Fabio Martelli, Dr, IRCCS Policlinico S. Donato
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RNA-HF-AS
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .