Stenosis, AorticOVERLOADNCT05768594
Omics in Valvular Disease
An observational study of Stenosis, Aortic, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The aim of our study is to investigate the effects of impaired left ventricular remodeling on the short- and long-term prognosis in AS partecipants undergoing extracorporeal circulation during valve repair surgery and in partecipants undergoing implantation transcatheter. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Stenosis, Aortic
- What is being tested?
- Blood sample
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 15 Nov 2019to 13 Dec 2023
- How long will I take part?
- 24 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 patients admitted to our Department will be enrolled in our study of Cardiovascular Sciences with a diagnosis of severe aortic stenosis and preserved ejection fraction echocardiographic evaluation, divided into two categories: 1. 15 patients undergoing surgical valve replacement (SAVR) 2. 15 patients undergoing transcatheter aortic valve replacement (TAVR)
Who may be able to join
- -30 patients with a diagnosis of severe aortic stenosis and preserved ejection fraction to echocardiographic evaluation
Who cannot join
- inflammatory;
- infectious diseases;
- neoplasms;
- ailments immunological or haematological;
- treatment with anti-inflammatory drugs except aspirin a low dose (75-160 mg);
- age > 85 years;
- advanced chronic kidney disease with filtrate glomerular heart rate (eGFR) estimated by MDRD equation <30 ml/min./1.73 m2.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Gemelli
Roma, 00168
Giovanna GL Liuzzo, +39 06/30154187, giovanna.liuzzo@policlinicogemelli.it
About this study
Official title: Omics in Valvular Disease: Biomarkers of Cardiac Remodeling, Left Ventricular Function, Intensive Care Unit Outcome, and Doppler Echocardiography (OVERLOAD)
The aim of our study is to investigate the effects of impaired left ventricular remodeling on the short- and long-term prognosis in AS partecipants undergoing extracorporeal circulation during valve repair surgery and in partecipants undergoing implantation transcatheter. For the achievement of these purposes, markers obtained from will be considered cardiovascular imaging methods, such as color Doppler echocardiography and isolated biomarkers from peripheral blood and heart tissue.
Read the detailed description
Participation in this study includes, following enrollment, a visit of follow up (6/12 months) on the occasion of a concomitant medical check-up scheduled according to normal clinical practice. During these visits venous and contextual blood samples will be taken echocardiographic examination for re-evaluation of ejection fraction, as per normal practice clinic. The only variant will be the withdrawal of an additional aliquot of blood during the sampling standard blood.
All enrolled partecipants will undergo the optimal medical treatment provided by current and more recent guidelines for the treatment of heart valve disease. Joining this study will not result any modification of the current therapy, which will be established by the attending physician according to the correct one clinical practice.
- Conditions
- Stenosis, Aortic
- Being tested
- Blood sample
- Keywords
- Transcatheter Aortic Valve Replacement, Surgical Aortic Valve Replacement
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Also called Color Doppler echocardiogram
After blood sampling, patients will undergo a Color Doppler Echocardiogram, a non-invasive method
| Study group | Role | What they receive |
|---|---|---|
| Patients with aortic stenosis, surgical valve replacement | 15 patients undergoing surgical valve replacement (SAVR) Receives: Other: Blood sample | |
| Patients with aortic stenosis, undergoing transcatheter aortic valve implantation | 15 patients undergoing transcatheter aortic valve replacement (TAVR) Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the two serum biomarkers of mitochondrial dysfunction
Description of the two serum biomarkers of mitochondrial dysfunction Myeloperoxidase (MPO) and Lactoferrin (LF) and the indices of myocardial performance, systolic and diastolic function of the left ventricle in patients undergoing invasive (SAVR) or non-invasive (TAVR) monitoring.
Measured: 1 year
Secondary outcomes (2)
Evaluation of the correlation between the two serum biomarkers of mitochondrial dysfunction
The two serum biomarkers and the myocardial performance indices, of the left ventricular systolic and diastolic function , evaluated in patients undergoing invasive (SAVR) or non-invasive monitoring (TAVR).
Measured: 6 months
Evaluation of gene expression of molecular pathways involved in ventricular remodeling and correlation with echocardiographic parameters of left ventricular performance.
The gene expression of the molecular pathways involved in ventricular remodeling and the correlation with echocardiographic parameters of left ventricular performance, will be evaluated through methods:
- peripheral blood sampling
- immunochemical analysis
- evaluation of the oxidant and anti-oxidant capacity in vitro
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start15 Nov 2019
- Primary completion5 Nov 2020
- Study completion13 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stenosis, AorticStudies 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
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 24 Years
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liuzzo Giovanna, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768594
- Sponsor's protocol ID
- 2821
- Acronym
- OVERLOAD
- Status last verified
- Mar 2023
- First submitted
- 22 Feb 2023
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omics in Valvular Disease: Biomarkers of Cardiac Remodeling, Left Ventricular Function, Intensive Care Unit Outcome, and Doppler Echocardiography (OVERLOAD)
- ClinicalTrials.gov ID
- NCT05768594
- Acronym / sponsor ID
- OVERLOAD / 2821
- Conditions
- Stenosis, Aortic
- Keywords
- Transcatheter Aortic Valve Replacement, Surgical Aortic Valve Replacement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 13 Dec 2023 (estimated)
- First posted
- 14 Mar 2023 (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.
The aim of our study is to investigate the effects of impaired left ventricular remodeling on the short- and long-term prognosis in AS partecipants undergoing extracorporeal circulation during valve repair surgery and in partecipants undergoing implantation transcatheter. For the achievement of these purposes, markers obtained from will be considered cardiovascular imaging methods, such as color Doppler echocardiography and isolated biomarkers from peripheral blood and heart tissue.
Detailed description
Participation in this study includes, following enrollment, a visit of follow up (6/12 months) on the occasion of a concomitant medical check-up scheduled according to normal clinical practice. During these visits venous and contextual blood samples will be taken echocardiographic examination for re-evaluation of ejection fraction, as per normal practice clinic. The only variant will be the withdrawal of an additional aliquot of blood during the sampling standard blood.
All enrolled partecipants will undergo the optimal medical treatment provided by current and more recent guidelines for the treatment of heart valve disease. Joining this study will not result any modification of the current therapy, which will be established by the attending physician according to the correct one clinical practice.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 24 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with aortic stenosis, surgical valve replacement | – | Other: Blood sample15 patients undergoing surgical valve replacement (SAVR) |
| Patients with aortic stenosis, undergoing transcatheter aortic valve implantation | – | Other: Blood sample15 patients undergoing transcatheter aortic valve replacement (TAVR) |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients admitted to our Department will be enrolled in our study of Cardiovascular Sciences with a diagnosis of severe aortic stenosis and preserved ejection fraction echocardiographic evaluation, divided into two categories: 1. 15 patients undergoing surgical valve replacement (SAVR) 2. 15 patients undergoing transcatheter aortic valve replacement (TAVR)
Key inclusion criteria (1 listed)
- -30 patients with a diagnosis of severe aortic stenosis and preserved ejection fraction to echocardiographic evaluation
Key exclusion criteria (7 listed)
- inflammatory;
- infectious diseases;
- neoplasms;
- ailments immunological or haematological;
- treatment with anti-inflammatory drugs except aspirin a low dose (75-160 mg);
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 |
|---|---|---|
| Blood sampleAlso: Color Doppler echocardiogramAfter blood sampling, patients will undergo a Color Doppler Echocardiogram, a non-invasive method | Other | Patients with aortic stenosis, surgical valve replacement, Patients with aortic stenosis, undergoing transcatheter aortic valve implantation |
Primary outcome
Description of the two serum biomarkers of mitochondrial dysfunction
Time frame: 1 year
Description of the two serum biomarkers of mitochondrial dysfunction Myeloperoxidase (MPO) and Lactoferrin (LF) and the indices of myocardial performance, systolic and diastolic function of the left ventricle in patients undergoing invasive (SAVR) or non-invasive (TAVR) monitoring.
2 secondary outcomes
Evaluation of the correlation between the two serum biomarkers of mitochondrial dysfunction
Time frame: 6 months
Evaluation of gene expression of molecular pathways involved in ventricular remodeling and correlation with echocardiographic parameters of left ventricular performance.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Individual participant dataSharing planned: Yes
Related trials for Stenosis, Aortic
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Not yet recruiting
A Clinical Trial to Evaluate the Effects of the NeuEve Dryness Treatment Kit on Vaginal Health, Comfort, and Quality of Life in Postmenopausal Women
Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
RecruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Non-obstructive Hypertrophic Cardiomyopathy
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stenosis, Aortic, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site 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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liuzzo LG Giovanna (+39 06/30154187, giovanna.liuzzo@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the two serum biomarkers of mitochondrial dysfunction (time frame: 1 year). 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 20 Mar 2023.