Heart Failure and Aortic Stenosis Transcriptome

Heart Failure Clinical Trial

— RNA-HF-AS  

Official title:

Study of the Transcriptomic Alterations in Heart Failure and Aortic Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03268135
• Other study ID #: RNA-HF-AS
• Status: Recruiting
• Start date: May 30, 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: IRCCS Policlinico S. Donato
• Contact: Fabio Martelli, Dr
• Phone: +39 02 26437762
• Email: fabio.martelli[@]grupposandonato.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic
• Heart Failure

Intervention

Diagnostic Test:
• measurement of RNAs

Locations

Country	Name	City	State
Italy	Ospedale San Raffaele	Milano
Italy	Irccs Policlinico San Donato	San Donato Milanese	Milan

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato	Ospedale San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac tissutal mRNAs signatures	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
Primary	Cardiac tissutal miRNAs signatures	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
Primary	Cardiac tissutal lncRNAs signatures	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
Secondary	Non end-stage, end-stage heart failure, aortic stenosis mRNAs signatures in plasmas	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
Secondary	Non end-stage, end-stage heart failure, aortic stenosis miRNAs signatures in plasmas	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
Secondary	Non end-stage, end-stage heart failure, aortic stenosis lncRNAs signatures in plasmas	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