Obesity & OverweightNCT07847307
ENDOBARIHEART STUDY
A study testing echocardiography, Coronary CT angiography and blood analysis in people with Obesity & Overweight, run by Maria Cecilia Hospital at 1 site in Italy.
Trial summary
The primary outcome of this study is to evaluate changes in cardiovascular risk after endoscopic sleeve gastroplasty (ESG) in patients at high cardiovascular risk, using the SCORE2 ( Systematic COronary Risk Evaluation 2) and SCORE2-OP ( Systematic COronary Risk Evaluation 2 Older Persons) risk scores, which estimate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- echocardiography, Coronary CT angiography and blood analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2026to 1 Dec 2028
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent
- obesity or overweight
- atherosclerotic cardiovascular disease
- type 1 or type 2 diabetes mellitus
- hypercholesterolemia or severe dyslipidemia
- evidence of subclinical atherosclerosis
Who cannot join
- chronic inflammatory diseases
- active viral or bacterial infections
- severe anaemia or severe coagulopathy
- severe chronic kidney failure
- active malignancy
- anticoagulant therapy
- chronic treatment with immunosuppressants/immunomodulators
- pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Maria Cecilia Hospital
Cotignola, Ravenna, 48033
Elisa Giacomini, +39 0545.217688, egiacomini@gvmnet.it
Margherita Tiezzi, MD
About this study
Official title: CARDIOVASCULAR RISK PROFILE IN HIGH CARDIOVASCULAR RISK OBESE PATIENTS BEFORE AND AFTER ANDOSCOPIC SLEEVE GASTROPLASTY: A PILOT STUDY
The primary outcome of this study is to evaluate changes in cardiovascular risk after endoscopic sleeve gastroplasty (ESG) in patients at high cardiovascular risk, using the SCORE2 ( Systematic COronary Risk Evaluation 2) and SCORE2-OP ( Systematic COronary Risk Evaluation 2 Older Persons) risk scores, which estimate the risk of having a cardiovascular event.
Read the detailed description
This study aims to evaluate whether endoscopic sleeve gastroplasty (ESG), a minimally invasive procedure that reduces the size of the stomach, may improve cardiovascular health in patients with a high risk of cardiovascular disease.
Cardiovascular risk refers to the likelihood of developing serious conditions such as heart attack or stroke. In this study, cardiovascular risk will be assessed using two validated risk scores: SCORE2 (Systematic COronary Risk Evaluation 2), used mainly in adults aged 40-69 years, and SCORE2-OP (Systematic COronary Risk Evaluation 2 - Older Persons), used in people aged 70 years and older. Risk modifiers include coronary calcium score (CAC), coronary angiography and the socioeconomic status, as well as the presence of specific comorbidities. Following recent scientific evidence, circulating biomarkers as well as imaging biomarkers like epicardial fat (EAT) characterization, the quantification of oxidative stress and the composition and role of gut microbiota are proposed to stratify and personalize the calculation of Cardiovascular risk (CV) and therefore improve CV prognosis
- Conditions
- Obesity & Overweight
- Being tested
- echocardiography, Coronary CT angiography, blood analysis
- Keywords
- Cardiovascular Risk, Cardiovascular Risk Factors, Endoscopic Sleeve Gastroplasty, Obesity
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiographyOther
Echocardiography will be performed in each patient The following parameters will be assessed: systolic function, diastolic function, presence/absence of ventricular hypertrophy, left atrial volume indexed (LAVi), left atrial strain (LAS), valvular morphology and function, estimated intracardiac pressures
Coronary CT angiographyRadiation
Coronary CT angiography has a duration of 10-15 minutes per patient and requires the use of contrast
blood analysisBiological
Blood count, liver and kidney function, coagulation assessment, C-reactive protein, glycaemic and lipidic profile
| Study group | Role | What they receive |
|---|---|---|
| Patients Undergoing Endoscopic Sleeve Gastroplasty | Other | A total of 20 mL will be collected. Urine samples will be collected before Endoscopic Sleeve Gastroplasty and in sterile conditions. Imaging techniques will be performed before ESG procedure as well. Receives: Other: echocardiography; Radiation: Coronary CT angiography; Biological: blood analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Systematic Coronary Risk Evaluation 2 ( SCORE 2) and Systematic Coronary Risk Evaluation 2 Older Persons (SCORE 2 OP) using algorithms after endoscopic sleeve gastroplasty.
Measured: From enrollment to the end of follow up at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Cecilia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847307
- Sponsor's protocol ID
- ENDOBARIHEART STUDY
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARDIOVASCULAR RISK PROFILE IN HIGH CARDIOVASCULAR RISK OBESE PATIENTS BEFORE AND AFTER ANDOSCOPIC SLEEVE GASTROPLASTY: A PILOT STUDY
- ClinicalTrials.gov ID
- NCT07847307
- Acronym / sponsor ID
- ENDOBARIHEART STUDY
- Conditions
- Obesity & Overweight
- Keywords
- Cardiovascular Risk, Cardiovascular Risk Factors, Endoscopic Sleeve Gastroplasty, Obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Maria Cecilia HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 29 Sep 2026 (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 primary outcome of this study is to evaluate changes in cardiovascular risk after endoscopic sleeve gastroplasty (ESG) in patients at high cardiovascular risk, using the SCORE2 ( Systematic COronary Risk Evaluation 2) and SCORE2-OP ( Systematic COronary Risk Evaluation 2 Older Persons) risk scores, which estimate the risk of having a cardiovascular event.
Detailed description
This study aims to evaluate whether endoscopic sleeve gastroplasty (ESG), a minimally invasive procedure that reduces the size of the stomach, may improve cardiovascular health in patients with a high risk of cardiovascular disease.
Cardiovascular risk refers to the likelihood of developing serious conditions such as heart attack or stroke. In this study, cardiovascular risk will be assessed using two validated risk scores: SCORE2 (Systematic COronary Risk Evaluation 2), used mainly in adults aged 40-69 years, and SCORE2-OP (Systematic COronary Risk Evaluation 2 - Older Persons), used in people aged 70 years and older. Risk modifiers include coronary calcium score (CAC), coronary angiography and the socioeconomic status, as well as the presence of specific comorbidities. Following recent scientific evidence, circulating biomarkers as well as imaging biomarkers like epicardial fat (EAT) characterization, the quantification of oxidative stress and the composition and role of gut microbiota are proposed to stratify and personalize the calculation of Cardiovascular risk (CV) and therefore improve CV prognosis
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing Endoscopic Sleeve Gastroplasty | Other | Other: echocardiography, Radiation: Coronary CT angiography, Biological: blood analysisA total of 20 mL will be collected. Urine samples will be collected before Endoscopic Sleeve Gastroplasty and in sterile conditions. Imaging techniques will be performed before ESG procedure as well. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- informed consent
- obesity or overweight
- atherosclerotic cardiovascular disease
- type 1 or type 2 diabetes mellitus
- hypercholesterolemia or severe dyslipidemia
Key exclusion criteria (8 listed)
- chronic inflammatory diseases
- active viral or bacterial infections
- severe anaemia or severe coagulopathy
- severe chronic kidney failure
- active malignancy
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 |
|---|---|---|
| echocardiographyEchocardiography will be performed in each patient The following parameters will be assessed: systolic function, diastolic function, presence/absence of ventricular hypertrophy, left atrial volume indexed (LAVi), left atrial strain (LAS), valvular morphology and function, estimated intracardiac pressures | Other | Patients Undergoing Endoscopic Sleeve Gastroplasty |
| Coronary CT angiographyCoronary CT angiography has a duration of 10-15 minutes per patient and requires the use of contrast | Radiation | Patients Undergoing Endoscopic Sleeve Gastroplasty |
| blood analysisBlood count, liver and kidney function, coagulation assessment, C-reactive protein, glycaemic and lipidic profile | Biological | Patients Undergoing Endoscopic Sleeve Gastroplasty |
Primary outcome
Changes in Systematic Coronary Risk Evaluation 2 ( SCORE 2) and Systematic Coronary Risk Evaluation 2 Older Persons (SCORE 2 OP) using algorithms after endoscopic sleeve gastroplasty.
Time frame: From enrollment to the end of follow up at 12 months
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 9 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing echocardiography, Coronary CT angiography and blood analysis in people with Obesity & Overweight, run by Maria Cecilia Hospital 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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 9 Oct 2026. 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?
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 Elisa Giacomini, PhD (+39 0545.217688, egiacomini@gvmnet.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Systematic Coronary Risk Evaluation 2 ( SCORE 2) and Systematic Coronary Risk Evaluation 2 Older Persons (SCORE 2 OP) using algorithms after endoscopic sleeve gastroplasty. (time frame: From enrollment to the end of follow up at 12 months). 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 9 Oct 2026.