HypertensionEYEBRAINNCT02701855
Retina Microvascular Remodeling and Cognitive Function In Hypertension
An observational study of Hypertension and Mild Cognitive Impairment, run by Institute of Cardiometabolism and Nutrition, France at 1 site in France.
Trial summary
This study aims to determine the relationships between retina micro-vascular remodeling and cognitive function in hypertensive patients. The study plans to enrol 160 patients (100 patients with mild cognitive impairment -MCI- and 60 without MCI). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypertension, Mild Cognitive Impairment
- What is being tested?
- Cognitive tests, Blood test and Brain and aorta RMI
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Dec 2017
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients' recruitment will be carried out in two centers to ensure inclusion of both patients: 1) with hypertension and without cognitive impairment, 2) with hypertension and with mild cognitive impairment (without dementia) including patients with stable MCI and converters. Population size: 160 patients: * 60 patients with hypertension and no MCI, * 50 patients with hypertension and stable MCI, without dementia * 50 patients with hypertension and progressive MCI, without dementia
Who may be able to join
- Aged 65 or more
- hypertension (BP ≥140/90 mmHg and/or antihypertensive treatment)
- Signed informed consent by the patient
- Sufficient mastery of the French language to perform neuropsychological tests
Who cannot join
- Impossibility to visualize the retinal : severe cataract
- Dementia (defined by MMSE<20)
- Clinical stroke
- Severe or resistant Hypertension
- Hypertension treated with more than 3 different pharmacological classes
- any other disease that may interfere with the assessment of cognitive disorders (epilepsy, Parkinson's disease, major depression, schizophrenia, manic-depressive)
Show all 14Show fewer
- Enrolment in a therapeutic trial that could interfere with the main objective
- Less than 4 years of formal education
- Illiterate, unable to read, write or count
- major physical problems that may interfere with the tests (sight, hearing, ...)
- Short term life threatening disease
- Non-affiliation to a healthcare system
- Consent refusal
- Contraindication to MRI including claustrophobia, metallic devices, pacemaker, mechanical valve implanted before 1985, and nursing, as well as technical contra-indication: patient diameter > 70 cm or/and weight > 250 kg
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Unité de prévention des maladies cardiovasculaires Pôle Cardiologie/Métabolisme Hôpital Pitié-Salpétriêre, APHP, 83 bd de l'hôpital,
Paris, 75013
David Rosenbaum, Dr
About this study
Official title: Retina Microvascular Remodeling and Cognitive Function In Hypertension : Eyebrain
This study aims to determine the relationships between retina micro-vascular remodeling and cognitive function in hypertensive patients.
The study plans to enrol 160 patients (100 patients with mild cognitive impairment -MCI- and 60 without MCI).
Read the detailed description
Our project stands on physiopathological and cognitive angles, and is mainly based on the major role of large and small arteries elasticity on cognitive aging. It will benefit from the recent innovative accurate and non invasive techniques such as MRI for central large arteries and adaptative optics for retina arterioles imaging.
Study population is the following:
- 60 patients with hypertension and no MCI,
- 50 patients with hypertension and stable MCI, without dementia
- 50 patients with hypertension and progressive MCI, without dementia
Every patients will perform a medical interview and examination, an MRI (brain + aorta), adaptative optics imaging, a cognitive tests and a blood test.
Primary outcome is to determine the relationships between retina micro-vascular remodeling and cognitive function in this population.
- Conditions
- Hypertension, Mild Cognitive Impairment
- Being tested
- Cognitive tests, Blood test, Brain and aorta RMI, Adaptative optics
- 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.
Cognitive testsBehavioural
Cognitive tests include:
- The MMSE (Mini Mental State Examination)
- Free and Cued Selective Recall Reminding Test (FCSRT).
- Executive functions (fluencies, TMT A and B, span).
- Tests of verbal fluency (literal and category)
- Digit symbol substitution test or Wechsler adult intelligence scale (W.A.I.S)
- The Clinical Dementia Rating Scale
- The IADL scale evaluates autonomy.
- Geriatric Depression screening Scale (GDS)
Blood testBiological
A blood test will be performed in order to collect following parameters: Urea, BUN, Creatinine, Potassium, Sodium, hematocrit, hsCRP, NFS, Pq, LDL-C, HDL-C, Triglycerides, Lp(a), Lp-PLA2 as well as fasting glucose, HbA1C and microalbuminuria
Brain and aorta RMIRadiation
A magnetic resonance imaging exam will be performed at the Neuroimaging Research Center of the Pitié-Salpêtrière Hospital. This exam will be optimized to fit in 30 minutes. Indeed brain 3D T1 and T2 FLAIR imaging lasts 15 minutes while cine and velocity encoded imaging of the aorta lasts 15 minutes.
Adaptative opticsOther
The retina adaptative optic imaging will be performed at the "Unité de prevention des maladies cardiovasculaires" Pitié Salpetrière Hospital. This exam lasts 10 minutes including patient positioning and imaging.
| Study group | Role | What they receive |
|---|---|---|
| Hypertension and progressive MCI | 50 subjects will perform brain and aorta RMI, blood test, cognitive tests and adaptative optics. Receives: Behavioral: Cognitive tests; Biological: Blood test; Radiation: Brain and aorta RMI; Other: Adaptative optics | |
| Hypertension and stable MCI | 50 subjects will perform brain and aorta RMI, blood test, cognitive tests and adaptative optics. Receives: Behavioral: Cognitive tests; Biological: Blood test; Radiation: Brain and aorta RMI; Other: Adaptative optics | |
| Hypertension, without MCI | 60 subjects will perform brain and aorta RMI, blood test, cognitive tests and adaptative optics. Receives: Behavioral: Cognitive tests; Biological: Blood test; Radiation: Brain and aorta RMI; Other: Adaptative optics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationships between retina micro-vascular remodeling and cognitive function in hypertensive patients.
Measured: September 2017
Secondary outcomes (6)
• Associations between cognitive function and proximal aortic stiffness indices estimated from MRI images.
Measured: September 2017
• Associations between retina arteriolar remodelling and cerebrovascular lesions (infarcts, lacuna, and white matter lesions) quantified from MRI images.
Measured: September 2017
• Associations between retina arteriolar remodelling and neurodegenerative lesions (hippocampus atrophy) quantified from MRI images.
Measured: September 2017
• Associations between proximal aortic stiffness and cerebrovascular lesions (infarcts, lacuna, and white matter lesions) quantified from MRI images.
Measured: September 2017
• Associations between proximal aortic stiffness and neurodegenerative lesions (hippocampus atrophy) quantified from MRI images.
Measured: September 2017
• Associations between retina arteriolar remodelling and proximal aortic stiffness indices.
Measured: September 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startOct 2014
- Primary completionSep 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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
- Case only
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Cardiometabolism and Nutrition, France
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de Recherche sur l'Hypertension Artérielle
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701855
- Sponsor's protocol ID
- 14DRM_EYEBRAIN
- Acronym
- EYEBRAIN
- Status last verified
- Mar 2016
- First submitted
- 4 Aug 2015
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ferri CP, Prince M, Brayne C, Brodaty H, Fratiglioni L, Ganguli M, Hall K, Hasegawa K, Hendrie H, Huang Y, Jorm A, Mathers C, Menezes PR, Rimmer E, Scazufca M; Alzheimer's Disease International. Global prevalence of dementia: a Delphi consensus study. Lancet. 2005 Dec 17;366(9503):2112-7. doi: 10.1016/S0140-6736(05)67889-0.
PubMed 16360788Luchsinger JA, Reitz C, Honig LS, Tang MX, Shea S, Mayeux R. Aggregation of vascular risk factors and risk of incident Alzheimer disease. Neurology. 2005 Aug 23;65(4):545-51. doi: 10.1212/01.wnl.0000172914.08967.dc.
PubMed 16116114Launer LJ, Ross GW, Petrovitch H, Masaki K, Foley D, White LR, Havlik RJ. Midlife blood pressure and dementia: the Honolulu-Asia aging study. Neurobiol Aging. 2000 Jan-Feb;21(1):49-55. doi: 10.1016/s0197-4580(00)00096-8.
PubMed 10794848Qiu C, Winblad B, Fratiglioni L. The age-dependent relation of blood pressure to cognitive function and dementia. Lancet Neurol. 2005 Aug;4(8):487-99. doi: 10.1016/S1474-4422(05)70141-1.
PubMed 16033691Perlmutter LS, Barron E, Saperia D, Chui HC. Association between vascular basement membrane components and the lesions of Alzheimer's disease. J Neurosci Res. 1991 Dec;30(4):673-81. doi: 10.1002/jnr.490300411.
PubMed 1787541Hardy JA, Mann DM, Wester P, Winblad B. An integrative hypothesis concerning the pathogenesis and progression of Alzheimer's disease. Neurobiol Aging. 1986 Nov-Dec;7(6):489-502. doi: 10.1016/0197-4580(86)90086-2.
PubMed 2882432Vagnucci AH Jr, Li WW. Alzheimer's disease and angiogenesis. Lancet. 2003 Feb 15;361(9357):605-8. doi: 10.1016/S0140-6736(03)12521-4.
PubMed 12598159Hanon O, Haulon S, Lenoir H, Seux ML, Rigaud AS, Safar M, Girerd X, Forette F. Relationship between arterial stiffness and cognitive function in elderly subjects with complaints of memory loss. Stroke. 2005 Oct;36(10):2193-7. doi: 10.1161/01.STR.0000181771.82518.1c. Epub 2005 Sep 8.
PubMed 16151027Redheuil A, Yu WC, Wu CO, Mousseaux E, de Cesare A, Yan R, Kachenoura N, Bluemke D, Lima JA. Reduced ascending aortic strain and distensibility: earliest manifestations of vascular aging in humans. Hypertension. 2010 Feb;55(2):319-26. doi: 10.1161/HYPERTENSIONAHA.109.141275. Epub 2010 Jan 11.
PubMed 20065154Redheuil A, Yu WC, Mousseaux E, Harouni AA, Kachenoura N, Wu CO, Bluemke D, Lima JA. Age-related changes in aortic arch geometry: relationship with proximal aortic function and left ventricular mass and remodeling. J Am Coll Cardiol. 2011 Sep 13;58(12):1262-70. doi: 10.1016/j.jacc.2011.06.012.
PubMed 21903061Rosenbaum D, Koch E, Girerd X, Rossant F, Paques M. [Imaging of retinal arteries with adaptative optics, feasibility and reproducibility]. Ann Cardiol Angeiol (Paris). 2013 Jun;62(3):184-8. doi: 10.1016/j.ancard.2013.04.017. Epub 2013 May 29. French.
PubMed 23773704Herment A, Kachenoura N, Lefort M, Bensalah M, Dogui A, Frouin F, Mousseaux E, De Cesare A. Automated segmentation of the aorta from phase contrast MR images: validation against expert tracing in healthy volunteers and in patients with a dilated aorta. J Magn Reson Imaging. 2010 Apr;31(4):881-8. doi: 10.1002/jmri.22124.
PubMed 20373432Bollache E, Kachenoura N, Redheuil A, Frouin F, Mousseaux E, Recho P, Lucor D. Descending aorta subject-specific one-dimensional model validated against in vivo data. J Biomech. 2014 Jan 22;47(2):424-31. doi: 10.1016/j.jbiomech.2013.11.009. Epub 2013 Nov 15.
PubMed 24290136Dogui A, Kachenoura N, Frouin F, Lefort M, De Cesare A, Mousseaux E, Herment A. Consistency of aortic distensibility and pulse wave velocity estimates with respect to the Bramwell-Hill theoretical model: a cardiovascular magnetic resonance study. J Cardiovasc Magn Reson. 2011 Jan 27;13(1):11. doi: 10.1186/1532-429X-13-11.
PubMed 21272312
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retina Microvascular Remodeling and Cognitive Function In Hypertension : Eyebrain
- ClinicalTrials.gov ID
- NCT02701855
- Acronym / sponsor ID
- EYEBRAIN / 14DRM_EYEBRAIN
- Conditions
- Hypertension, Mild Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Institute of Cardiometabolism and Nutrition, FranceUniversity, hospital or other
- Collaborators
- Fondation de Recherche sur l'Hypertension Artérielle
- Study start
- Oct 2014
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 8 Mar 2016 (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.
This study aims to determine the relationships between retina micro-vascular remodeling and cognitive function in hypertensive patients.
The study plans to enrol 160 patients (100 patients with mild cognitive impairment -MCI- and 60 without MCI).
Detailed description
Our project stands on physiopathological and cognitive angles, and is mainly based on the major role of large and small arteries elasticity on cognitive aging. It will benefit from the recent innovative accurate and non invasive techniques such as MRI for central large arteries and adaptative optics for retina arterioles imaging.
Study population is the following:
- 60 patients with hypertension and no MCI,
- 50 patients with hypertension and stable MCI, without dementia
- 50 patients with hypertension and progressive MCI, without dementia
Every patients will perform a medical interview and examination, an MRI (brain + aorta), adaptative optics imaging, a cognitive tests and a blood test.
Primary outcome is to determine the relationships between retina micro-vascular remodeling and cognitive function in this population.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypertension and progressive MCI | – | Behavioral: Cognitive tests, Biological: Blood test, Radiation: Brain and aorta RMI, Other: Adaptative optics50 subjects will perform brain and aorta RMI, blood test, cognitive tests and adaptative optics. |
| Hypertension and stable MCI | – | Behavioral: Cognitive tests, Biological: Blood test, Radiation: Brain and aorta RMI, Other: Adaptative optics50 subjects will perform brain and aorta RMI, blood test, cognitive tests and adaptative optics. |
| Hypertension, without MCI | – | Behavioral: Cognitive tests, Biological: Blood test, Radiation: Brain and aorta RMI, Other: Adaptative optics60 subjects will perform brain and aorta RMI, blood test, cognitive tests and adaptative optics. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients' recruitment will be carried out in two centers to ensure inclusion of both patients: 1) with hypertension and without cognitive impairment, 2) with hypertension and with mild cognitive impairment (without dementia) including patients with stable MCI and converters. Population size: 160 patients: * 60 patients with hypertension and no MCI, * 50 patients with hypertension and stable MCI, without dementia * 50 patients with hypertension and progressive MCI, without dementia
Key inclusion criteria (4 listed)
- Aged 65 or more
- hypertension (BP ≥140/90 mmHg and/or antihypertensive treatment)
- Signed informed consent by the patient
- Sufficient mastery of the French language to perform neuropsychological tests
Key exclusion criteria (14 listed)
- Impossibility to visualize the retinal : severe cataract
- Dementia (defined by MMSE<20)
- Clinical stroke
- Severe or resistant Hypertension
- Hypertension treated with more than 3 different pharmacological classes
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 |
|---|---|---|
| Cognitive testsCognitive tests include: * The MMSE (Mini Mental State Examination) * Free and Cued Selective Recall Reminding Test (FCSRT). * Executive functions (fluencies, TMT A and B, span). * Tests of verbal fluency (literal and category) * Digit symbol substitution test or Wechsler adult intelligence scale (W.A.I.S) * The Clinical Dementia Rating Scale * The IADL scale evaluates autonomy. * Geriatric Depression screening Scale (GDS) | Behavioural | Hypertension and progressive MCI, Hypertension and stable MCI, Hypertension, without MCI |
| Blood testA blood test will be performed in order to collect following parameters: Urea, BUN, Creatinine, Potassium, Sodium, hematocrit, hsCRP, NFS, Pq, LDL-C, HDL-C, Triglycerides, Lp(a), Lp-PLA2 as well as fasting glucose, HbA1C and microalbuminuria | Biological | Hypertension and progressive MCI, Hypertension and stable MCI, Hypertension, without MCI |
| Brain and aorta RMIA magnetic resonance imaging exam will be performed at the Neuroimaging Research Center of the Pitié-Salpêtrière Hospital. This exam will be optimized to fit in 30 minutes. Indeed brain 3D T1 and T2 FLAIR imaging lasts 15 minutes while cine and velocity encoded imaging of the aorta lasts 15 minutes. | Radiation | Hypertension and progressive MCI, Hypertension and stable MCI, Hypertension, without MCI |
| Adaptative opticsThe retina adaptative optic imaging will be performed at the "Unité de prevention des maladies cardiovasculaires" Pitié Salpetrière Hospital. This exam lasts 10 minutes including patient positioning and imaging. | Other | Hypertension and progressive MCI, Hypertension and stable MCI, Hypertension, without MCI |
Primary outcome
Relationships between retina micro-vascular remodeling and cognitive function in hypertensive patients.
Time frame: September 2017
6 secondary outcomes
• Associations between cognitive function and proximal aortic stiffness indices estimated from MRI images.
Time frame: September 2017
• Associations between retina arteriolar remodelling and cerebrovascular lesions (infarcts, lacuna, and white matter lesions) quantified from MRI images.
Time frame: September 2017
• Associations between retina arteriolar remodelling and neurodegenerative lesions (hippocampus atrophy) quantified from MRI images.
Time frame: September 2017
• Associations between proximal aortic stiffness and cerebrovascular lesions (infarcts, lacuna, and white matter lesions) quantified from MRI images.
Time frame: September 2017
• Associations between proximal aortic stiffness and neurodegenerative lesions (hippocampus atrophy) quantified from MRI images.
Time frame: September 2017
• Associations between retina arteriolar remodelling and proximal aortic stiffness indices.
Time frame: September 2017
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Background: PubMed 16360788Ferri CP, Prince M, Brayne C, Brodaty H, Fratiglioni L, Ganguli M, Hall K, Hasegawa K, Hendrie H, Huang Y, Jorm A, Mathers C, Menezes PR, Rimmer E, Scazufca M; Alzheimer's Disease International. Global prevalence of dementia: a Delphi consensus study. Lancet. 2005 Dec 17;366(9503):2112-7. doi: 10.1016/S0140-6736(05)67889-0.
- Background: PubMed 16116114Luchsinger JA, Reitz C, Honig LS, Tang MX, Shea S, Mayeux R. Aggregation of vascular risk factors and risk of incident Alzheimer disease. Neurology. 2005 Aug 23;65(4):545-51. doi: 10.1212/01.wnl.0000172914.08967.dc.
- Background: PubMed 10794848Launer LJ, Ross GW, Petrovitch H, Masaki K, Foley D, White LR, Havlik RJ. Midlife blood pressure and dementia: the Honolulu-Asia aging study. Neurobiol Aging. 2000 Jan-Feb;21(1):49-55. doi: 10.1016/s0197-4580(00)00096-8.
- Background: PubMed 16033691Qiu C, Winblad B, Fratiglioni L. The age-dependent relation of blood pressure to cognitive function and dementia. Lancet Neurol. 2005 Aug;4(8):487-99. doi: 10.1016/S1474-4422(05)70141-1.
- Background: PubMed 1787541Perlmutter LS, Barron E, Saperia D, Chui HC. Association between vascular basement membrane components and the lesions of Alzheimer's disease. J Neurosci Res. 1991 Dec;30(4):673-81. doi: 10.1002/jnr.490300411.
- Background: PubMed 2882432Hardy JA, Mann DM, Wester P, Winblad B. An integrative hypothesis concerning the pathogenesis and progression of Alzheimer's disease. Neurobiol Aging. 1986 Nov-Dec;7(6):489-502. doi: 10.1016/0197-4580(86)90086-2.
- Background: PubMed 12598159Vagnucci AH Jr, Li WW. Alzheimer's disease and angiogenesis. Lancet. 2003 Feb 15;361(9357):605-8. doi: 10.1016/S0140-6736(03)12521-4.
- Background: PubMed 16151027Hanon O, Haulon S, Lenoir H, Seux ML, Rigaud AS, Safar M, Girerd X, Forette F. Relationship between arterial stiffness and cognitive function in elderly subjects with complaints of memory loss. Stroke. 2005 Oct;36(10):2193-7. doi: 10.1161/01.STR.0000181771.82518.1c. Epub 2005 Sep 8.
- Background: PubMed 20065154Redheuil A, Yu WC, Wu CO, Mousseaux E, de Cesare A, Yan R, Kachenoura N, Bluemke D, Lima JA. Reduced ascending aortic strain and distensibility: earliest manifestations of vascular aging in humans. Hypertension. 2010 Feb;55(2):319-26. doi: 10.1161/HYPERTENSIONAHA.109.141275. Epub 2010 Jan 11.
- Background: PubMed 21903061Redheuil A, Yu WC, Mousseaux E, Harouni AA, Kachenoura N, Wu CO, Bluemke D, Lima JA. Age-related changes in aortic arch geometry: relationship with proximal aortic function and left ventricular mass and remodeling. J Am Coll Cardiol. 2011 Sep 13;58(12):1262-70. doi: 10.1016/j.jacc.2011.06.012.
- Background: PubMed 23773704Rosenbaum D, Koch E, Girerd X, Rossant F, Paques M. [Imaging of retinal arteries with adaptative optics, feasibility and reproducibility]. Ann Cardiol Angeiol (Paris). 2013 Jun;62(3):184-8. doi: 10.1016/j.ancard.2013.04.017. Epub 2013 May 29. French.
- Background: PubMed 20373432Herment A, Kachenoura N, Lefort M, Bensalah M, Dogui A, Frouin F, Mousseaux E, De Cesare A. Automated segmentation of the aorta from phase contrast MR images: validation against expert tracing in healthy volunteers and in patients with a dilated aorta. J Magn Reson Imaging. 2010 Apr;31(4):881-8. doi: 10.1002/jmri.22124.
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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 and Mild Cognitive Impairment, run by Institute of Cardiometabolism and Nutrition, France at 1 site in France.
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 4 inclusion and 14 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 8 Mar 2016. 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 France. 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 David Rosenbaum, Dr (01 42 17 57 74 ext. +33, david.rosenbaum@psl.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationships between retina micro-vascular remodeling and cognitive function in hypertensive patients. (time frame: September 2017). 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 NCT02701855, which also lists 14 linked publications.
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 8 Mar 2016.