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Clinical Trials in Italy / NCT07847307
Starting soon Not applicable

ENDOBARIHEART STUDY

NCT07847307 · tracked via the Priya Life Science Italy tracker
Sponsor
Maria Cecilia Hospital
Phase
Not applicable
Started
2026-10-01
Last updated
2026-09-29

Condition(s) studied

Obesity & Overweight

Investigational drug(s) / intervention(s)

echocardiographyCoronary CT angiographyblood analysis

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * informed consent * obesity or overweight * atherosclerotic cardiovascular disease * type 1 or type 2 diabetes mellitus * hypercholesterolemia or severe dyslipidemia * evidence of subclinical atherosclerosis Exclusion Criteria: * 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

Primary outcome measure(s)

  • Quantification of the impact of endoscopic sleeve gastroplasty on Cardiovascular risk — From enrollment to the end of follow up at 12 months

Trial sites (1)

FacilityCityRegionStatus
Maria Cecilia Hospital Cotignola Ravenna

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07847307 on ClinicalTrials.gov ↗ ← All trials in Italy