Evaluation of Splenic Metabolic Activity With 18FDG-PET in Hypertension

The purpose of this study is to evaluate the splenic activation in hypertensive patients, as compared to normotensives, using FDG-PET/CT imaging. Moreover, the investigators will investigate whether the splenic metabolic activity relates to the expression of circulating inflammatory proteins (high-sensitivity C-reactive protein [hsCRP]), interleukin-1b (IL-1b), tumor necrosis factor-a (TNF-a) or to immune profiles of activated T cells.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Other: PET/CT scan

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Giuseppe Lembo, MD in Cardiology; Phone Number: +39 0865.915225; Email: lembo@neuromed.it

Study Locations

• Italy
  • (is)
    • Pozzilli, (is), Italy, 86077
      • Recruiting
      • IRCCS Neuromed
      • Principal Investigator: Giuseppe Lembo, prof., MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects will be selected from patients who will undergo FDG-PET/CT imaging of chest and abdomen in the Department of Nuclear Medicine of IRCCS Neuromed, accordingly to the following inclusion/exclusion criteria. All the enrolled patients must have an indication for FDG-PET/CT. Approximately 120 hypertensive and normotensive subjects of both genders (at least 45 per group, in order to have the appropriate statistical power) will be included in the study.

Description

Inclusion Criteria:

• absence of prior cancer diagnosis or remission from cancer at the time of FDG-PET/CT imaging (from at least 6 months)
• age ≥ 30 and ≤ 85 years
• absence of acute cardio/cerebrovascular disease (myocardial infarction, stroke, transient ischemic attack, revascularization)
• absence of acute or chronic inflammatory or autoimmune disease
• diagnosis of presence/absence of hypertension, on the basis of documented medical history

Exclusion Criteria:

• diabetes
• atrial fibrillation
• use of anti-inflammatory drugs in the week preceding the FDG-PET/CT imaging
• chronic use of anti-inflammatory drugs

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normotensive; Normotensive subjects	Other: PET/CT scan; PET/CT scan
Hypertensive; Hypertensive subjects	Other: PET/CT scan; PET/CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Splenic metabolic activity	18FDG uptake in splenic tissue	At enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circulating pro-inflammatory markers	Serum levels of pro-inflammatory cytokines	At enrollment

Collaborators and Investigators

• Sponsor: Neuromed IRCCS

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2018
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): September 1, 2023

Study Registration Dates

• First Submitted: October 7, 2015
• First Submitted That Met QC Criteria: October 8, 2015
• First Posted (ESTIMATE): October 9, 2015

Study Record Updates

• Last Update Posted (ACTUAL): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 8, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: LMB05