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

NCT ID: NCT02572765

Last Updated: 2022-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-02

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normotensive

Normotensive subjects

PET/CT scan

Intervention Type OTHER

PET/CT scan

Hypertensive

Hypertensive subjects

PET/CT scan

Intervention Type OTHER

PET/CT scan

Interventions

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PET/CT scan

PET/CT scan

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Neuromed IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Lembo

prof. Giuseppe Lembo

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Neuromed

Pozzilli, (IS), Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giuseppe Lembo, MD in Cardiology

Role: CONTACT

+39 0865.915225

Other Identifiers

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LMB05

Identifier Type: -

Identifier Source: org_study_id

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