ENDOBARIHEART STUDY

NCT07847307 | Not Yet Recruiting

• 1 other identifier: ENDOBARIHEART STUDY
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 the risk of having a cardiovascular event.

Conditions

Obesity & Overweight

Keywords

Cardiovascular Risk; Cardiovascular Risk Factors; Endoscopic Sleeve Gastroplasty; Obesity

Outcome Measures

Primary Outcomes (1)

• Quantification of the impact of endoscopic sleeve gastroplasty on Cardiovascular risk

  From enrollment to the end of follow up at 12 months

Study Arms (1)

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.

Other: echocardiography; Radiation: Coronary CT angiography; Biological: blood analysis

Interventions

echocardiography OTHER

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

Patients Undergoing Endoscopic Sleeve Gastroplasty

Coronary CT angiography RADIATION

Coronary CT angiography has a duration of 10-15 minutes per patient and requires the use of contrast

Patients Undergoing Endoscopic Sleeve Gastroplasty

blood analysis BIOLOGICAL

Blood count, liver and kidney function, coagulation assessment, C-reactive protein, glycaemic and lipidic profile

Patients Undergoing Endoscopic Sleeve Gastroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• informed consent
• obesity or overweight
• atherosclerotic cardiovascular disease
• type 1 or type 2 diabetes mellitus
• hypercholesterolemia or severe dyslipidemia
• evidence of subclinical atherosclerosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Maria Cecilia Hospital: lead

Study Sites (1)

Maria Cecilia Hospital

Cotignola, Ravenna, 48033, Italy

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Elisa Giacomini, PhD

CONTACT

+39 0545.217688; egiacomini@gvmnet.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 29, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)