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Status unknownNCT02572765Updated Apr 11, 2022

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

An observational study in Hypertension, sponsored by Neuromed IRCCS. Status unknown at 1 site in Italy. Open to participants aged 30 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-11.

Sponsored by Neuromed IRCCS · Observational

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
30 Years to 85 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Hypertension

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In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 120 is below the median of 210 across 1,359 observational studies indexed under Hypertension.

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Lead sponsor

Neuromed IRCCS is the lead sponsor of 76 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Normotensive

    Normotensive subjects

    Other: PET/CT scan

  • Hypertensive

    Hypertensive subjects

    Other: PET/CT scan

Interventions

  • OtherPET/CT scan

    PET/CT scan

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What researchers measure

Primary outcomes

  1. Splenic metabolic activity

    18FDG uptake in splenic tissue

    Time frame: At enrollment

Secondary outcomes

  1. Circulating pro-inflammatory markers

    Serum levels of pro-inflammatory cytokines

    Time frame: At enrollment

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Study locations

1 of 1 sites recruiting
  • IRCCS Neuromed
    Pozzilli, (is) 86077, Italy
    • Giuseppe Lembo, prof., MD, PhD · Principal investigator
    • Daniela Carnevale, PhD · Sub investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02572765
Lead sponsor
Neuromed IRCCS
Responsible party
Giuseppe Lembo (prof. Giuseppe Lembo, Neuromed IRCCS) — Principal investigator
First posted
Oct 9, 2015
Start date
Jan 2, 2018
Primary completion
Dec 2022 (estimated)
Completion
Sep 2023 (estimated)
Last update
Apr 11, 2022

Study contacts

Giuseppe Lembo, MD in Cardiology
Contact
lembo@neuromed.it
+39 0865.915225
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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