Arterial HypertensionNCT06098300
Effects of Change in Blood Pressure on Retinal Capillary Rarefaction in Patients With Arterial Hypertension
An observational study of Arterial Hypertension and Blood Pressure, High, run by Medical University of Vienna at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Arterial Hypertension, Blood Pressure, High
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 1 Sep 2023to Aug 2025
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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) with a planned initiation or planned adaption of antihypertensive medication by the Department of Cardiology.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Gerhard Garhöfer, Assoc. Prof. Priv. Doz. MD contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Gerhard Garhöfer, Assoc. Prof. PD MD, 0043 1 40400 29880, gerhard.garhoefer@meduniwien.ac.at
About this study
Official title: Effects of Change in Blood Pressure on Retinal Capillary Rarefaction in Patients With Arterial Hypertension - a Pilot Study
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.
Read the detailed description
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.
- Conditions
- Arterial Hypertension, Blood Pressure, High
- Keywords
- Retinal Capillary Rarefaction, Hypertension, Antihypertensive medication, OCT-A, Retinal oxygen extraction, Choroidal vascularity index (CVI), Ocular blood flow
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in retinal vessel density after achieving blood pressure treatment target (OCT-A).
As OCT devices are able to calculate the movements of erythrocytes, retinal perfusion can be visualized with Optical Coherence Tomography Angiography. No contrast media is necessary for the representation of retinal vessels.
Measured: 12 weeks
Secondary outcomes (7)
Change in choroidal vascularity index after achieving blood pressure treatment target (EDI-OCT).
The choroid will be imaged with the enhanced-depth-imaging-OCT (EDI-OCT) (Spectralis, Heidelberg Engineering, Heidelberg, Germany). By using an automatic detection algorithm, developed by Tian et al., the choroid will be separated from the sclera and Bruch´s membrane. Afterwards, the image will be binarized using the software Fiji ImageJ. An autolocal threshold will be applied and the image will be converted into an RGB (red, green, blue) image, thereby determining the luminal area of the choroid. The choroidal vascularity index is obtained by dividing the luminal area by the total choroidal area.
Measured: 12 weeks
Change in neurovascular coupling after achieving blood pressure treatment target (DVA).
The DVA allows for the real time measurement of retinal vessel diameters in vivo. The DVA is a commercially available system (IMEDOS, Jena, Germany) which comprises a fundus camera, a video camera, a real time monitor and a personal computer with an analyzing software for the accurate determination of retinal arterial and venous diameters. Every second a maximum of 25 readings of vessel diameter can be obtained. For this purpose the fundus is imaged onto the charge coupled device chip of the video camera. The consecutive fundus images are digitized using a frame grabber. In addition, the fundus image can be inspected on the real time monitor and, if necessary, stored on a video recorder. Evaluation of the retinal vessel diameters can either be done online or offline from the recorded video tapes.
Measured: 12 weeks
Change in retinal oxygen saturation after achieving blood pressure treatment target (DVA).
Retinal oxygen saturation measurement is based on the image analysis by the oxygen module of the commercially available Dynamic Vessel Analyzer (DVA, Imedos, Germany). Two monochromatic fundus images are recorded by the retinal oximeter. In an image, obtained by the camera and filter assembly, the operator has to mark the vessel of interest by a mouse click. The vessel is traced automatically applying the following procedure. The vessel walls are located as photometric edges in the vicinity of the mouse cursor in the green channel image. If edges are determined, the search is continued in their proximity.
Measured: 12 weeks
Change in ocular blood flow after achieving blood pressure treatment target (LSFG).
A commercially available LSFG (Nidek, Japan) system will be used in the present study. The LSFG device consists of a fundus camera equipped with a diode laser with a wavelength of 830 nm and a charge-coupled device. NB, the relative velocity of blood flow, is derived from the pattern of speckle contrast produced by the interference of a laser scattered by blood cells moving in the ocular fundus. Images are acquired continuously at the rate of 30 frames per seconds in a 4-second time period and stored on a personal computer. Equipped analysis software synchronizes the captured MBR images in each cardiac cycle, and averages the MBR in each heartbeat to produce a heartbeat map of the ONH and the retina/choroid.
Measured: 12 weeks
Change in retinal oxygen extraction after achieving blood pressure treatment target.
Retinal oxygen extraction will be determined by measuring retinal blood flow (LSFG), retinal oxygen saturation (DVA) and retinal vessel diameter (DVA). For the calculation of retinal oxygen extraction, the formula of Werkmeister et al. will be used, which will be slightly modified as retinal blood flow is measured with LSFG and not with Doppler OCT.
Measured: 12 weeks
Change in ocular perfusion pressure and arterial blood pressure after achieving blood pressure treatment target.
mOPP = 2/3 mBP- IOP Blood pressure will be measured with an automated oscillometric device
Measured: 12 weeks
Change in retinal vessel diameter after achieving blood pressure treatment target (DVA).
Two monochromatic fundus images are recorded by the retinal oximeter. In an image, obtained by the camera and filter assembly, the operator has to mark the vessel of interest by a mouse click. The vessel is traced automatically applying the following procedure. The vessel walls are located as photometric edges in the vicinity of the mouse cursor in the green channel image. If edges are determined, the search is continued in their proximity.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start1 Sep 2023
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098300
- Sponsor's protocol ID
- OPHT-240323
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mills KT, Stefanescu A, He J. The global epidemiology of hypertension. Nat Rev Nephrol. 2020 Apr;16(4):223-237. doi: 10.1038/s41581-019-0244-2. Epub 2020 Feb 5.
PubMed 32024986Dai H, Bragazzi NL, Younis A, Zhong W, Liu X, Wu J, Grossman E. Worldwide Trends in Prevalence, Mortality, and Disability-Adjusted Life Years for Hypertensive Heart Disease From 1990 to 2017. Hypertension. 2021 Apr;77(4):1223-1233. doi: 10.1161/HYPERTENSIONAHA.120.16483. Epub 2021 Feb 15.
PubMed 33583201Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; Authors/Task Force Members:. 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension. J Hypertens. 2018 Oct;36(10):1953-2041. doi: 10.1097/HJH.0000000000001940.
PubMed 30234752Dziedziak J, Zaleska-Zmijewska A, Szaflik JP, Cudnoch-Jedrzejewska A. Impact of Arterial Hypertension on the Eye: A Review of the Pathogenesis, Diagnostic Methods, and Treatment of Hypertensive Retinopathy. Med Sci Monit. 2022 Jan 20;28:e935135. doi: 10.12659/MSM.935135.
PubMed 35046380Oh JS, Lee CH, Park JI, Park HK, Hwang JK. Hypertension-Mediated Organ Damage and Long-term Cardiovascular Outcomes in Asian Hypertensive Patients without Prior Cardiovascular Disease. J Korean Med Sci. 2020 Dec 14;35(48):e400. doi: 10.3346/jkms.2020.35.e400.
PubMed 33316856Unger T, Borghi C, Charchar F, Khan NA, Poulter NR, Prabhakaran D, Ramirez A, Schlaich M, Stergiou GS, Tomaszewski M, Wainford RD, Williams B, Schutte AE. 2020 International Society of Hypertension Global Hypertension Practice Guidelines. Hypertension. 2020 Jun;75(6):1334-1357. doi: 10.1161/HYPERTENSIONAHA.120.15026. Epub 2020 May 6. No abstract available.
PubMed 32370572Wong TY, Mitchell P. The eye in hypertension. Lancet. 2007 Feb 3;369(9559):425-35. doi: 10.1016/S0140-6736(07)60198-6.
PubMed 17276782Kurniawan ED, Cheung N, Cheung CY, Tay WT, Saw SM, Wong TY. Elevated blood pressure is associated with rarefaction of the retinal vasculature in children. Invest Ophthalmol Vis Sci. 2012 Jan 31;53(1):470-4. doi: 10.1167/iovs.11-8835.
PubMed 22205607Chua J, Chin CWL, Hong J, Chee ML, Le TT, Ting DSW, Wong TY, Schmetterer L. Impact of hypertension on retinal capillary microvasculature using optical coherence tomographic angiography. J Hypertens. 2019 Mar;37(3):572-580. doi: 10.1097/HJH.0000000000001916.
PubMed 30113530Jumar A, Harazny JM, Ott C, Kistner I, Friedrich S, Schmieder RE. Improvement in Retinal Capillary Rarefaction After Valsartan Treatment in Hypertensive Patients. J Clin Hypertens (Greenwich). 2016 Nov;18(11):1112-1118. doi: 10.1111/jch.12851. Epub 2016 Jun 16.
PubMed 27306560Bosch AJ, Harazny JM, Kistner I, Friedrich S, Wojtkiewicz J, Schmieder RE. Retinal capillary rarefaction in patients with untreated mild-moderate hypertension. BMC Cardiovasc Disord. 2017 Dec 21;17(1):300. doi: 10.1186/s12872-017-0732-x.
PubMed 29268712Chua J, Le TT, Tan B, Ke M, Li C, Wong DWK, Tan ACS, Lamoureux E, Wong TY, Chin CWL, Schmetterer L. Choriocapillaris microvasculature dysfunction in systemic hypertension. Sci Rep. 2021 Feb 25;11(1):4603. doi: 10.1038/s41598-021-84136-6.
PubMed 33633311Schrimpf C, Teebken OE, Wilhelmi M, Duffield JS. The role of pericyte detachment in vascular rarefaction. J Vasc Res. 2014;51(4):247-58. doi: 10.1159/000365149. Epub 2014 Sep 3.
PubMed 25195856Estato V, Obadia N, Carvalho-Tavares J, Freitas FS, Reis P, Castro-Faria Neto H, Lessa MA, Tibirica E. Blockade of the renin-angiotensin system improves cerebral microcirculatory perfusion in diabetic hypertensive rats. Microvasc Res. 2013 May;87:41-9. doi: 10.1016/j.mvr.2013.02.007. Epub 2013 Mar 1.
PubMed 23466285Sabino B, Lessa MA, Nascimento AR, Rodrigues CA, Henriques Md, Garzoni LR, Levy BI, Tibirica E. Effects of antihypertensive drugs on capillary rarefaction in spontaneously hypertensive rats: intravital microscopy and histologic analysis. J Cardiovasc Pharmacol. 2008 Apr;51(4):402-9. doi: 10.1097/FJC.0b013e3181673bc5.
PubMed 18427284
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Change in Blood Pressure on Retinal Capillary Rarefaction in Patients With Arterial Hypertension - a Pilot Study
- ClinicalTrials.gov ID
- NCT06098300
- Acronym / sponsor ID
- OPHT-240323
- Conditions
- Arterial Hypertension, Blood Pressure, High
- Keywords
- Retinal Capillary Rarefaction, Hypertension, Antihypertensive medication, OCT-A, Retinal oxygen extraction, Choroidal vascularity index (CVI), Ocular blood flow
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 24 Oct 2023 (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.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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) with a planned initiation or planned adaption of antihypertensive medication by the Department of Cardiology.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
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
Change in retinal vessel density after achieving blood pressure treatment target (OCT-A).
Time frame: 12 weeks
As OCT devices are able to calculate the movements of erythrocytes, retinal perfusion can be visualized with Optical Coherence Tomography Angiography. No contrast media is necessary for the representation of retinal vessels.
7 secondary outcomes
Change in choroidal vascularity index after achieving blood pressure treatment target (EDI-OCT).
Time frame: 12 weeks
Change in neurovascular coupling after achieving blood pressure treatment target (DVA).
Time frame: 12 weeks
Change in retinal oxygen saturation after achieving blood pressure treatment target (DVA).
Time frame: 12 weeks
Change in ocular blood flow after achieving blood pressure treatment target (LSFG).
Time frame: 12 weeks
Change in retinal oxygen extraction after achieving blood pressure treatment target.
Time frame: 12 weeks
Change in ocular perfusion pressure and arterial blood pressure after achieving blood pressure treatment target.
Time frame: 12 weeks
Change in retinal vessel diameter after achieving blood pressure treatment target (DVA).
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 32024986Mills KT, Stefanescu A, He J. The global epidemiology of hypertension. Nat Rev Nephrol. 2020 Apr;16(4):223-237. doi: 10.1038/s41581-019-0244-2. Epub 2020 Feb 5.
- Background: PubMed 33583201Dai H, Bragazzi NL, Younis A, Zhong W, Liu X, Wu J, Grossman E. Worldwide Trends in Prevalence, Mortality, and Disability-Adjusted Life Years for Hypertensive Heart Disease From 1990 to 2017. Hypertension. 2021 Apr;77(4):1223-1233. doi: 10.1161/HYPERTENSIONAHA.120.16483. Epub 2021 Feb 15.
- Background: PubMed 30234752Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; Authors/Task Force Members:. 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension. J Hypertens. 2018 Oct;36(10):1953-2041. doi: 10.1097/HJH.0000000000001940.
- Background: PubMed 35046380Dziedziak J, Zaleska-Zmijewska A, Szaflik JP, Cudnoch-Jedrzejewska A. Impact of Arterial Hypertension on the Eye: A Review of the Pathogenesis, Diagnostic Methods, and Treatment of Hypertensive Retinopathy. Med Sci Monit. 2022 Jan 20;28:e935135. doi: 10.12659/MSM.935135.
- Background: PubMed 33316856Oh JS, Lee CH, Park JI, Park HK, Hwang JK. Hypertension-Mediated Organ Damage and Long-term Cardiovascular Outcomes in Asian Hypertensive Patients without Prior Cardiovascular Disease. J Korean Med Sci. 2020 Dec 14;35(48):e400. doi: 10.3346/jkms.2020.35.e400.
- Background: PubMed 32370572Unger T, Borghi C, Charchar F, Khan NA, Poulter NR, Prabhakaran D, Ramirez A, Schlaich M, Stergiou GS, Tomaszewski M, Wainford RD, Williams B, Schutte AE. 2020 International Society of Hypertension Global Hypertension Practice Guidelines. Hypertension. 2020 Jun;75(6):1334-1357. doi: 10.1161/HYPERTENSIONAHA.120.15026. Epub 2020 May 6. No abstract available.
- Background: PubMed 17276782Wong TY, Mitchell P. The eye in hypertension. Lancet. 2007 Feb 3;369(9559):425-35. doi: 10.1016/S0140-6736(07)60198-6.
- Background: PubMed 22205607Kurniawan ED, Cheung N, Cheung CY, Tay WT, Saw SM, Wong TY. Elevated blood pressure is associated with rarefaction of the retinal vasculature in children. Invest Ophthalmol Vis Sci. 2012 Jan 31;53(1):470-4. doi: 10.1167/iovs.11-8835.
- Background: PubMed 30113530Chua J, Chin CWL, Hong J, Chee ML, Le TT, Ting DSW, Wong TY, Schmetterer L. Impact of hypertension on retinal capillary microvasculature using optical coherence tomographic angiography. J Hypertens. 2019 Mar;37(3):572-580. doi: 10.1097/HJH.0000000000001916.
- Background: PubMed 27306560Jumar A, Harazny JM, Ott C, Kistner I, Friedrich S, Schmieder RE. Improvement in Retinal Capillary Rarefaction After Valsartan Treatment in Hypertensive Patients. J Clin Hypertens (Greenwich). 2016 Nov;18(11):1112-1118. doi: 10.1111/jch.12851. Epub 2016 Jun 16.
- Background: PubMed 29268712Bosch AJ, Harazny JM, Kistner I, Friedrich S, Wojtkiewicz J, Schmieder RE. Retinal capillary rarefaction in patients with untreated mild-moderate hypertension. BMC Cardiovasc Disord. 2017 Dec 21;17(1):300. doi: 10.1186/s12872-017-0732-x.
- Background: PubMed 33633311Chua J, Le TT, Tan B, Ke M, Li C, Wong DWK, Tan ACS, Lamoureux E, Wong TY, Chin CWL, Schmetterer L. Choriocapillaris microvasculature dysfunction in systemic hypertension. Sci Rep. 2021 Feb 25;11(1):4603. doi: 10.1038/s41598-021-84136-6.
- Description: Medical University of Vienna, Department of Clinical PharmacologyLink provided by the sponsor.
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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.
Gerhard Garhöfer, Assoc. Prof. Priv. Doz. MD contact
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 Arterial Hypertension and Blood Pressure, High, run by Medical University of Vienna at 1 site in Austria.
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 7 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 19 Sep 2024. 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 Austria. 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 Gerhard Garhöfer, Assoc. Prof. Priv. Doz. MD (01 40400 29880, klin-pharmakologie@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in retinal vessel density after achieving blood pressure treatment target (OCT-A). (time frame: 12 weeks). 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 NCT06098300, which also lists 31 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 19 Sep 2024.