NCT03268135

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 (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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started May 2016

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
May 2016Dec 2027

Study Start

First participant enrolled

May 30, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

8.6 years

First QC Date

July 17, 2017

Last Update Submit

April 29, 2025

Conditions

Heart FailureAortic Stenosis

Keywords

miRNAlncRNAstranscriptomeheart failureaortic stenosisbiomarkers

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • Non end-stage, end-stage heart failure, aortic stenosis mRNAs signatures in plasmas

    from Year 3 to Year 5

  • Non end-stage, end-stage heart failure, aortic stenosis miRNAs signatures in plasmas

    from Year 3 to Year 5

  • Non end-stage, end-stage heart failure, aortic stenosis lncRNAs signatures in plasmas

    from Year 3 to Year 5

Study Arms (4)

Non end-stage heart failure

Measurement of RNAs in non end-stage heart failure patients undergoing to left ventricle reconstruction

Diagnostic Test: measurement of RNAs

End-stage heart failure

Measurement of RNAs in end-stage heart failure patients undergoing to left ventricular assisted device (LVAD)

Diagnostic Test: measurement of RNAs

Aortic Stenosis

Measurement of RNAs in patients affected by cardiac hypertrophy leading to aortic stenosis and requiring cardiac myectomy

Diagnostic Test: measurement of RNAs

Controls

Measurement of RNAs in individuals not affected by cardiovascular diseases

Diagnostic Test: measurement of RNAs

Interventions

measurement of RNAsDIAGNOSTIC_TEST
Aortic StenosisControlsEnd-stage heart failureNon end-stage heart failure

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cardiac surgery patients

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Irccs Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

RECRUITING

Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

cardiac tissue and blood samples

MeSH Terms

Conditions

Heart FailureAortic Valve Stenosis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesAortic Valve DiseaseHeart Valve DiseasesVentricular Outflow Obstruction

Study Officials

  • Fabio Martelli, Dr

    IRCCS Policlinico S. Donato

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio Martelli, Dr

CONTACT

+39 02 26437762fabio.martelli@grupposandonato.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr, PhD, Molecular Cardiology Laboratory Director

Study Record Dates

First Submitted

July 17, 2017

First Posted

August 31, 2017

Study Start

May 30, 2016

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2027

Last Updated

April 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)