Menu
Recruiting NCT03268135

Heart Failure and Aortic Stenosis Transcriptome

— Observational Heart Failure Aortic Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: measurement of RNAs.
Who it may be relevant to
Registry conditions: Heart Failure, Aortic Stenosis. Basic parameters: 40 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Study of the Transcriptomic Alterations in Heart Failure and Aortic Stenosis

Overview

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.

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 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.

Interventions

  • Diagnostic test measurement of RNAs

Primary outcome measures

  • Cardiac tissutal mRNAs signatures [Time frame: from Year 1 to Year 3]
  • Cardiac tissutal miRNAs signatures [Time frame: from Year 1 to Year 3]
  • Cardiac tissutal lncRNAs signatures [Time frame: from Year 1 to Year 3]
Secondary outcome measures (3)
  • Non end-stage, end-stage heart failure, aortic stenosis mRNAs signatures in plasmas [Time frame: from Year 3 to Year 5]
  • Non end-stage, end-stage heart failure, aortic stenosis miRNAs signatures in plasmas [Time frame: from Year 3 to Year 5]
  • Non end-stage, end-stage heart failure, aortic stenosis lncRNAs signatures in plasmas [Time frame: from Year 3 to Year 5]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Italy · 2 centers
  • Irccs Policlinico San Donato — San Donato Milanese
  • Ospedale San Raffaele — Milan

Identifiers

NCT: NCT03268135 · RNA-HF-AS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗