Heart FailureRNA-HF-ASNCT03268135
Heart Failure and Aortic Stenosis Transcriptome
An observational study of Heart Failure and Aortic Stenosis, run by IRCCS Policlinico S. Donato at 2 sites in Italy.
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). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Heart Failure, Aortic Stenosis
- What is being tested?
- measurement of RNAs
- How many people
- 500 participants
- Where
- 2 sitesItaly
- Study dates
- 30 May 2016to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiac surgery patients
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Ospedale San Raffaele
Milan, 20132
Michele De Bonis, MD, PhD, debonis.michele@hsr.it
MICHELE DE BONIS, MD FESC FAHA
- Recruiting
Irccs Policlinico San Donato
San Donato Milanese, Milan, 20097
FABIO MARTELLI, PhD, 0252774683, fabio.martelli@grupposandonato.it
LORENZO MENICANTI, MD
About this study
Official title: Study of the Transcriptomic Alterations in Heart Failure and Aortic Stenosis
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.
Read the 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.
- Conditions
- Heart Failure, Aortic Stenosis
- Being tested
- measurement of RNAs
- Keywords
- miRNA, lncRNAs, transcriptome, heart failure, aortic stenosis, biomarkers
- Medical subject headings
- Heart Failure, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of RNAsDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Non end-stage heart failure | Measurement of RNAs in non end-stage heart failure patients undergoing to left ventricle reconstruction Receives: 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) Receives: Diagnostic Test: measurement of RNAs | |
| Aortic Stenosis | Measurement of RNAs in patients affected by cardiac hypertrophy leading to aortic stenosis and requiring cardiac myectomy Receives: Diagnostic Test: measurement of RNAs | |
| Controls | Measurement of RNAs in individuals not affected by cardiovascular diseases Receives: Diagnostic Test: measurement of RNAs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: from Year 1 to Year 3
Secondary outcomes (3)
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
Measured: from Year 3 to Year 5
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
Measured: from Year 3 to Year 5
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
Measured: from Year 3 to Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start30 May 2016
- Primary completion31 Dec 2024
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale San Raffaele
- Responsible party
- Principal investigator, Fabio Martelli, IRCCS Policlinico S. Donato
- Investigators
- Fabio Martelli, Dr, Principal investigator, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268135
- Sponsor's protocol ID
- RNA-HF-AS
- Acronym
- RNA-HF-AS
- Status last verified
- Apr 2025
- First submitted
- 17 Jul 2017
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Transcriptomic Alterations in Heart Failure and Aortic Stenosis
- ClinicalTrials.gov ID
- NCT03268135
- Acronym / sponsor ID
- RNA-HF-AS / RNA-HF-AS
- Conditions
- Heart Failure, Aortic Stenosis
- Keywords
- miRNA, lncRNAs, transcriptome, heart failure, aortic stenosis, biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Collaborators
- Ospedale San Raffaele
- Study start
- 30 May 2016 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non end-stage heart failure | – | Diagnostic Test: measurement of RNAsMeasurement of RNAs in non end-stage heart failure patients undergoing to left ventricle reconstruction |
| End-stage heart failure | – | Diagnostic Test: measurement of RNAsMeasurement of RNAs in end-stage heart failure patients undergoing to left ventricular assisted device (LVAD) |
| Aortic Stenosis | – | Diagnostic Test: measurement of RNAsMeasurement of RNAs in patients affected by cardiac hypertrophy leading to aortic stenosis and requiring cardiac myectomy |
| Controls | – | Diagnostic Test: measurement of RNAsMeasurement of RNAs in individuals not affected by cardiovascular diseases |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac surgery patients
Key inclusion criteria (15 listed)
- Non end-stage heart failure
- End-stage heart failure
- Aortic Stenosis
Key exclusion criteria (33 listed)
- Non end-stage heart failure
- End-stage heart failure
- Aortic Stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurement of RNAs | Diagnostic test | Aortic Stenosis, Controls, End-stage heart failure, Non end-stage heart failure |
Primary outcome
Cardiac tissutal mRNAs signatures
Time frame: 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
Cardiac tissutal miRNAs signatures
Time frame: 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
Cardiac tissutal lncRNAs signatures
Time frame: 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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabio Martelli, Dr principal investigator
IRCCS Policlinico S. Donato
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Aortic Stenosis, run by IRCCS Policlinico S. Donato at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabio Martelli, Dr (+39 02 26437762, fabio.martelli@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac tissutal mRNAs signatures (time frame: from Year 1 to Year 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.