Assessing Cardiovascular Dysfunction Pre- & Post-treatment in Inflammatory Bowel Diseases

National and Kapodistrian University of Athens

Status: Unknown

Conditions: Inflammatory Bowel Diseases

Study type: Observational

Funder types: Other

Identifiers

NCT03615287

42/25-01-18

Details and patient eligibility

About

The aim of this study is to compare medical and surgery treatment in IBD patients and healthy controls, by assessing the endothelial and cardiac function and the inflammation status.

Full description

The aim of this study is to compare medical and surgery treatment in IBD patients and healthy controls, by assessing the endothelial and cardiac function and the inflammation status.

In particular, three subject groups will be enrolled, as follows:

40 patients [Crohn's disease (CD) & ulcerative colitis (UC)] who will undergo medical treatment (Group A), 40 patients (CD & UC) who will undergo surgery (Group B) and a healthy control group (Group C) comprising 40 subjects.

Assessment of the inflammation load (CRP, WBC, IL-6, TNFa), the endothelial function (FMD, PWV, cIMT, endothelial glycocalyx) and the cardiac function - via echocardiographic parameters (systolic and diastolic echo values, tissue doppler imaging-GLS-strain rate) - will be carried out for every subject group in two phases: prior to treatment and four months after the treatment, as applicable.

The objective is to investigate whether there is a statistically significant reduction of endothelial and cardiac dysfunction following medical and surgery treatment in IBD patients as well as to examine associations across the three groups.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with IBD diagnosed > 6 months via biopsy confirming the diagnosis
• Patients with IBD at an advanced & non-controllable phase (IBD scores,clinical status, endoscopic and biochemical values) requiring the initiation of a new medical treatment or surgical intervention.

Exclusion criteria

• Coronary Artery Disease
• Peripheral Arterial Disease
• Thromboembolic Disease (acute or chronic)
• Heart failure of any cause
• Valvular Disease
• Congenital Heart Defect
• Heart Rhythm Disorder
• Stroke, Renal or liver failure, malignancy, endocrine disorder
• Other autoimmune disorder or angiitis
• IBD diagnosed < 6 months
• BMI > 40 Kg/m2

Trial design

120 participants in 3 patient groups

Group A

Description:

40 subjects undergoing Medical Treatment

Group B

Description:

40 subjects undergoing Surgical Treatment

Group C

Description:

40 control subjects