HypertensionNCT02572765
Evaluation of Splenic Metabolic Activity With 18FDG-PET in Hypertension
An observational study of Hypertension, run by Neuromed IRCCS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- PET/CT scan
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2018to Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- diabetes
- atrial fibrillation
- use of anti-inflammatory drugs in the week preceding the FDG-PET/CT imaging
- chronic use of anti-inflammatory drugs
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Neuromed
Pozzilli, (IS), 86077
Giuseppe Lembo, prof., MD, PhD
Daniela Carnevale, PhD
About this study
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.
- Conditions
- Hypertension
- Being tested
- PET/CT scan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT scanOther
PET/CT scan
| Study group | Role | What they receive |
|---|---|---|
| Normotensive | Normotensive subjects Receives: Other: PET/CT scan | |
| Hypertensive | Hypertensive subjects Receives: Other: PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Splenic metabolic activity
18FDG uptake in splenic tissue
Measured: At enrollment
Secondary outcomes (1)
Circulating pro-inflammatory markers
Serum levels of pro-inflammatory cytokines
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study start2 Jan 2018
- Primary completionDec 2022 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Lembo, Neuromed IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572765
- Sponsor's protocol ID
- LMB05
- Status last verified
- Apr 2022
- First submitted
- 7 Oct 2015
- Last updated
- 11 Apr 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Splenic Metabolic Activity With 18FDG-PET in Hypertension
- ClinicalTrials.gov ID
- NCT02572765
- Acronym / sponsor ID
- LMB05
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 9 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normotensive | – | Other: PET/CT scanNormotensive subjects |
| Hypertensive | – | Other: PET/CT scanHypertensive subjects |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- diabetes
- atrial fibrillation
- use of anti-inflammatory drugs in the week preceding the FDG-PET/CT imaging
- chronic use of anti-inflammatory drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CT scanPET/CT scan | Other | Hypertensive, Normotensive |
Primary outcome
Splenic metabolic activity
Time frame: At enrollment
18FDG uptake in splenic tissue
1 secondary outcome
Circulating pro-inflammatory markers
Time frame: At enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Neuromed IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Lembo, MD in Cardiology (+39 0865.915225, lembo@neuromed.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Splenic metabolic activity (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.