HypertensionNCT02310217
Validation of New Tools for the Assessment of Cognitive Functions and Connectivity Network in Hypertensive Patients
An observational study of Hypertension and Cognitive Impairment, run by Neuromed IRCCS at 1 site in Italy.
Trial summary
The relationship among hypertension, aging and cognitive decline is complex and not completely understood. Purpose of this project will be evaluating early markers of cognitive deterioration in patients with arterial hypertension. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Hypertension, Cognitive Impairment
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2015to Dec 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be selected from the Department of Angiocardioneurology and Translational Medicine of the IRCCS Neuromed, according to specific inclusion criteria. Approximatey 80 subjects per group, aged between 40 and 65 years, will be included in the study.
Who may be able to join
- Males or females diagnosed with arterial hypertension between 40 and 65 years of age;
- Written informed consent prior to enrollment in the study.
Who cannot join
- Precedent acute myocardial infarction (AMI);
- Previous stroke and/or transient ischemic attack (TIA);
- Previous or concomitant neurologic or psychiatric pathologies;
- Neurologic or psychiatric pharmacological therapy.
Trial locations and contacts
1 site in 1 country.
About this study
The relationship among hypertension, aging and cognitive decline is complex and not completely understood. Purpose of this project will be evaluating early markers of cognitive deterioration in patients with arterial hypertension. In particular, this cross-sectional observational study will be articulated in three phases:
- Neuropsychological evaluation of general cognitive abilities
- Identification and measurement of specific biomarker levels
- Correlation among hypertension, cognitive abilities and biomarkers.
- Conditions
- Hypertension, Cognitive Impairment
- Keywords
- Hypertension, Cognitive impairment, Biomarkers
- Medical subject headings
- Hypertension, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Hypertensive | |
| 2 | Normotensive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive abilities measured by validated neuropsychological test battery (Montreal Cognitive Assessment test, Verbal Fluency test,learning of couple words, Stroop test)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (actual)
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
- NCT02310217
- Sponsor's protocol ID
- LMB03
- Status last verified
- Apr 2022
- First submitted
- 28 Nov 2014
- Last updated
- 20 Apr 2022
- Results posted
- No
Publications
Carnevale L, Maffei A, Landolfi A, Grillea G, Carnevale D, Lembo G. Brain Functional Magnetic Resonance Imaging Highlights Altered Connections and Functional Networks in Patients With Hypertension. Hypertension. 2020 Nov;76(5):1480-1490. doi: 10.1161/HYPERTENSIONAHA.120.15296. Epub 2020 Sep 21.
PubMed 32951470
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of New Tools for the Assessment of Cognitive Functions and Connectivity Network in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT02310217
- Acronym / sponsor ID
- LMB03
- Conditions
- Hypertension, Cognitive Impairment
- Keywords
- Hypertension, Cognitive impairment, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 8 Dec 2014 (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 relationship among hypertension, aging and cognitive decline is complex and not completely understood. Purpose of this project will be evaluating early markers of cognitive deterioration in patients with arterial hypertension. In particular, this cross-sectional observational study will be articulated in three phases:
- Neuropsychological evaluation of general cognitive abilities
- Identification and measurement of specific biomarker levels
- Correlation among hypertension, cognitive abilities and biomarkers.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Hypertensive |
| 2 | – | –Normotensive |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected from the Department of Angiocardioneurology and Translational Medicine of the IRCCS Neuromed, according to specific inclusion criteria. Approximatey 80 subjects per group, aged between 40 and 65 years, will be included in the study.
Key inclusion criteria (2 listed)
- Males or females diagnosed with arterial hypertension between 40 and 65 years of age;
- Written informed consent prior to enrollment in the study.
Key exclusion criteria (4 listed)
- Precedent acute myocardial infarction (AMI);
- Previous stroke and/or transient ischemic attack (TIA);
- Previous or concomitant neurologic or psychiatric pathologies;
- Neurologic or psychiatric pharmacological therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive abilities measured by validated neuropsychological test battery (Montreal Cognitive Assessment test, Verbal Fluency test,learning of couple words, Stroop test)
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Derived from this study: PubMed 32951470Carnevale L, Maffei A, Landolfi A, Grillea G, Carnevale D, Lembo G. Brain Functional Magnetic Resonance Imaging Highlights Altered Connections and Functional Networks in Patients With Hypertension. Hypertension. 2020 Nov;76(5):1480-1490. doi: 10.1161/HYPERTENSIONAHA.120.15296. Epub 2020 Sep 21.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Cognitive Impairment, 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 2 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: finished, as of the sponsor's last update on 20 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive abilities measured by validated neuropsychological test battery (Montreal Cognitive Assessment test, Verbal Fluency test,learning of couple words, Stroop test) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02310217, which also lists 1 linked publication.
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 20 Apr 2022.