HypertensionNCT03986957
Novel Approaches of Advanced Neuroimaging Based on MRI Fiber Tracking to Detect Early Signs of Vascular Cognitive Impairment in Hypertensive Patients
An observational study of Hypertension, run by Neuromed IRCCS at 1 site in Italy.
Trial summary
Hypertension is the major risk factor for vascular cognitive impairment (VCI). One of the main limitations in the clinical approach to VCI is that, by the time that it is manifested, it might be too late to reverse the neurodegenerative process. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Hypertension
- How many people
- 176 participants
- Where
- 1 siteItaly
- Study dates
- 9 Dec 2019to 8 Dec 2022
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be selected from patients attending the Department of AngioCardioNeurology of the IRCCS Neuromed, accordingly to the following inclusion/exclusion criteria. Approximately 176 subjects of both genders will be included in the study.
Who may be able to join
- age ≥ 40 and ≤ 70 years
- patients with moderate hypertension
- written informed consent
Who cannot join
- previous IMA, stroke or TIA
- arrhythmia or severe cardiac disease
- Diabetes or renal disease
- psychiatric disease
- neurological or neurodegenerative disease
- dementia
Show all 9Show fewer
- assumption of drugs known to interfere with cognitive function
- inability to be subjected MRI analysis
- participation to other clinical trial, ongoing or terminated less than one month before enrolment in this study.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Neuromed
Pozzilli, Isernia, 86077
Giuseppe Lembo, MD, PhD, +39 0865.915225, lembo@neuromed.it
Giuseppe Lembo, MD, PhD
About this study
Hypertension is the major risk factor for vascular cognitive impairment (VCI). One of the main limitations in the clinical approach to VCI is that, by the time that it is manifested, it might be too late to reverse the neurodegenerative process. Thus, early identification of predictive signs of later dementia is demanding for management of hypertensive patients (HT).This aim claims for new methods that compute in a cloud all possible data sources coming from patients (brain imaging, cognitive profile, clinical data), to extract discriminative aggregate biomarkers. Thus, this study aims at: 1) characterizing the predictive potential of an aggregate biomarker for dementia in HT, based on brain imaging, clinical and cognitive assessment; 2) evaluating the impact of blood pressure variability, besides systolic/diastolic blood pressure, on the progression of the aggregate biomarker; 3) assessing whether specific classes of antihypertensive drugs differently affect the progression of the aggregate biomarker. In order to do this, this study proposes to evaluate advanced brain imaging and cognitive profile in a cohort of hypertensive patients, at baseline and after a 1 year follow up, to identify an innovative signature for the development of cognitive dysfunction in hypertension. In particular, the effects of blood pressure variability and of different classes of antihypertensive drugs will be evaluated.
- Conditions
- Hypertension
- Being tested
- No interventions
- Keywords
- Vascular Cognitive Impairment, Magnetic Resonance Imaging, Blood Pressure Variability
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
No interventions - observational study
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive patients | Patients with SBP: 140-159; DBP: 90-99 Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of percentage change in diffusion parameters of the white matter
Fiber tracking by DTI MRI
Measured: At Enrollment; at 1 year Follow-up
Secondary outcomes (4)
Detection of cognitive decline by decrease of MoCA score
Cognitive tests
Measured: At Enrollment; at 1 year Follow-up
Characterization of cardiac hypertensive organ damage progression
Echography
Measured: At Enrollment; at 1 year Follow-up
Characterization of renal hypertensive organ damage progression
eGFR
Measured: At Enrollment; at 1 year Follow-up
Characterization of Blood Pressure Variability
24h registration of systolic and diastolic blood pressure
Measured: At Enrollment; at 1 year Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start9 Dec 2019
- Primary completion8 Dec 2022 (estimated)
- Study completion8 Dec 2022 (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
- Case only
- Time perspective
- Prospective
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Multimedica
- Responsible party
- Principal investigator, Giuseppe Lembo, Neuromed IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986957
- Sponsor's protocol ID
- LMB07
- Status last verified
- Jan 2022
- First submitted
- 10 Jun 2019
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Approaches of Advanced Neuroimaging Based on MRI Fiber Tracking to Detect Early Signs of Vascular Cognitive Impairment in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT03986957
- Acronym / sponsor ID
- LMB07
- Conditions
- Hypertension
- Keywords
- Vascular Cognitive Impairment, Magnetic Resonance Imaging, Blood Pressure Variability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Collaborators
- IRCCS Multimedica
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 8 Dec 2022 (estimated)
- Study completion
- 8 Dec 2022 (estimated)
- First posted
- 14 Jun 2019 (actual)
- 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.
Hypertension is the major risk factor for vascular cognitive impairment (VCI). One of the main limitations in the clinical approach to VCI is that, by the time that it is manifested, it might be too late to reverse the neurodegenerative process. Thus, early identification of predictive signs of later dementia is demanding for management of hypertensive patients (HT).This aim claims for new methods that compute in a cloud all possible data sources coming from patients (brain imaging, cognitive profile, clinical data), to extract discriminative aggregate biomarkers. Thus, this study aims at: 1) characterizing the predictive potential of an aggregate biomarker for dementia in HT, based on brain imaging, clinical and cognitive assessment; 2) evaluating the impact of blood pressure variability, besides systolic/diastolic blood pressure, on the progression of the aggregate biomarker; 3) assessing whether specific classes of antihypertensive drugs differently affect the progression of the aggregate biomarker. In order to do this, this study proposes to evaluate advanced brain imaging and cognitive profile in a cohort of hypertensive patients, at baseline and after a 1 year follow up, to identify an innovative signature for the development of cognitive dysfunction in hypertension. In particular, the effects of blood pressure variability and of different classes of antihypertensive drugs will be evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertensive patients | – | Other: No interventionsPatients with SBP: 140-159; DBP: 90-99 |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be selected from patients attending the Department of AngioCardioNeurology of the IRCCS Neuromed, accordingly to the following inclusion/exclusion criteria. Approximately 176 subjects of both genders will be included in the study.
Key inclusion criteria (3 listed)
- age ≥ 40 and ≤ 70 years
- patients with moderate hypertension
- written informed consent
Key exclusion criteria (9 listed)
- previous IMA, stroke or TIA
- arrhythmia or severe cardiac disease
- Diabetes or renal disease
- psychiatric disease
- neurological or neurodegenerative disease
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 |
|---|---|---|
| No interventionsNo interventions - observational study | Other | Hypertensive patients |
Primary outcome
Measurement of percentage change in diffusion parameters of the white matter
Time frame: At Enrollment; at 1 year Follow-up
Fiber tracking by DTI MRI
4 secondary outcomes
Detection of cognitive decline by decrease of MoCA score
Time frame: At Enrollment; at 1 year Follow-up
Characterization of cardiac hypertensive organ damage progression
Time frame: At Enrollment; at 1 year Follow-up
Characterization of renal hypertensive organ damage progression
Time frame: At Enrollment; at 1 year Follow-up
Characterization of Blood Pressure Variability
Time frame: At Enrollment; at 1 year Follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: No
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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 3 inclusion and 9 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 4 Jan 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, PhD (+390865915225, lembo@neuromed.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of percentage change in diffusion parameters of the white matter (time frame: At Enrollment; at 1 year Follow-up). 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 4 Jan 2022.