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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02572765
Recruitment Status : Recruiting
First Posted : October 9, 2015
Last Update Posted : June 17, 2019
Information provided by (Responsible Party):
Giuseppe Lembo, Neuromed IRCCS

Brief 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.

Condition or disease Intervention/treatment
Hypertension Other: PET/CT scan

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Splenic Metabolic Activity With 18FDG-PET in Hypertension
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Normotensive subjects
Other: PET/CT scan
PET/CT scan

Hypertensive subjects
Other: PET/CT scan
PET/CT scan

Primary Outcome Measures :
  1. Splenic metabolic activity [ Time Frame: At enrollment ]
    18FDG uptake in splenic tissue

Secondary Outcome Measures :
  1. Circulating pro-inflammatory markers [ Time Frame: At enrollment ]
    Serum levels of pro-inflammatory cytokines

Biospecimen Retention:   Samples Without DNA
Total blood and serum

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02572765

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Contact: Giuseppe Lembo, MD in Cardiology +39 0865.915225

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IRCCS Neuromed Recruiting
Pozzilli, (is), Italy, 86077
Principal Investigator: Giuseppe Lembo, prof., MD, PhD         
Sub-Investigator: Daniela Carnevale, PhD         
Sponsors and Collaborators
Neuromed IRCCS
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Responsible Party: Giuseppe Lembo, prof. Giuseppe Lembo, Neuromed IRCCS Identifier: NCT02572765    
Other Study ID Numbers: LMB05
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases