Effects of Change in Blood Pressure on Retinal Capillary Rarefaction in Patients With Arterial Hypertension
NCT ID: NCT06098300
Last Updated: 2024-09-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
30 participants
Study Classification
OBSERVATIONAL
Study Start Date
2023-09-01
Study Completion Date
2025-08-31
Brief Summary
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To evaluate whether in patients with initially poorly-controlled arterial hypertension, structural and functional differences in the retina and choroid remain after achieving a well-controlled blood pressure.
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Detailed Description
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Optical Coherence Tomography Angiography (OCT-A) is an ocular imaging technique which allows fast and non-invasive assessment of the retinal microvasculature. With the OCT-A, a reduction in capillary density in patients with arterial hypertension has been found. In animal experiments, this so called retinal capillary rarefaction could be reversed after administration of antihypertensive medication.
The main aim of the present study is to evaluate whether in patients with initially poorly-controlled hypertension, an increase in capillary density can be demonstrated, if patients achieve well-controlled blood pressure with antihypertensive medication. In addition changes in retinal oxygen metabolism and choroidal blood flow will be investigated.
The main aim of the present study is to evaluate whether in patients with initially poorly-controlled hypertension, an increase in capillary density can be demonstrated, if patients achieve well-controlled blood pressure with antihypertensive medication. In addition changes in retinal oxygen metabolism and choroidal blood flow will be investigated.
Conditions
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Arterial Hypertension
Blood Pressure, High
Study Design
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Observational Model Type
OTHER
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Men and Women aged ≥ 18 years
* Signed informed consent
* Apart from hypertensive retinopathy, normal ophthalmic findings
* Non-Smokers
* Patients with initially diagnosed or pre-existing mild to moderate primary arterial hypertension (systolic office blood pressure ≥ 140 mmHg and/or diastolic office blood pressure ≥ 90 mmHg)
* Planned initiation of antihypertensive medication or planned adaption of antihypertensive medication by the Department of Cardiology
* Subject agrees to perform regular blood pressure self-measurements and to document blood pressure values in a diary
* Signed informed consent
* Apart from hypertensive retinopathy, normal ophthalmic findings
* Non-Smokers
* Patients with initially diagnosed or pre-existing mild to moderate primary arterial hypertension (systolic office blood pressure ≥ 140 mmHg and/or diastolic office blood pressure ≥ 90 mmHg)
* Planned initiation of antihypertensive medication or planned adaption of antihypertensive medication by the Department of Cardiology
* Subject agrees to perform regular blood pressure self-measurements and to document blood pressure values in a diary
Exclusion Criteria
* Participation in a clinical trial in the three weeks preceding the study
* Blood donation in the three weeks preceding the study
* Symptoms of a clinically relevant illness in the three weeks preceding the study
* History of family history of epilepsy
* Secondary hypertension (e.g.: hyperaldosteronism, pheochromocytoma, renal artery stenosis, renal parenchymal diseases, Cushing-syndrome, Coarctatio aortae)
* History of hypertensive encephalopathy or intracerebral bleeding
* Diabetes mellitus Type 1 or Type 2
* Pregnant or breast-feeding women
* Women of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception
* Blood donation in the three weeks preceding the study
* Symptoms of a clinically relevant illness in the three weeks preceding the study
* History of family history of epilepsy
* Secondary hypertension (e.g.: hyperaldosteronism, pheochromocytoma, renal artery stenosis, renal parenchymal diseases, Cushing-syndrome, Coarctatio aortae)
* History of hypertensive encephalopathy or intracerebral bleeding
* Diabetes mellitus Type 1 or Type 2
* Pregnant or breast-feeding women
* Women of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception
Minimum Eligible Age
18 Years
Maximum Eligible Age
90 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Medical University of Vienna
OTHER
Sponsor Role
lead
Responsible Party
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Gerhard Garhofer
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Medical University of Vienna
Vienna, , Austria
Site Status
RECRUITING
Countries
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Austria
Central Contacts
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Facility Contacts
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References
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Related Links
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https://klinische-pharmakologie.meduniwien.ac.at/
Description: Medical University of Vienna, Department of Clinical Pharmacology
Other Identifiers
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OPHT-240323
Identifier Type: -
Identifier Source: org_study_id
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