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Recruiting NCT06098300

Effects of Change in Blood Pressure on Retinal Capillary Rarefaction in Patients With Arterial Hypertension

— Observational Arterial Hypertension Blood Pressure, High

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Arterial Hypertension, Blood Pressure, High. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effects of Change in Blood Pressure on Retinal Capillary Rarefaction in Patients With Arterial Hypertension - a Pilot Study

Overview

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.

Primary outcome measures

  • Change in retinal vessel density after achieving blood pressure treatment target (OCT-A). [Time frame: 12 weeks]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Austria · 1 center
  • Medical University of Vienna — Vienna

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. PMID 32024986
  • Dai 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. PMID 33583201
  • Williams 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 PMID 30234752
  • Dziedziak 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. PMID 35046380
  • Oh 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. PMID 33316856
  • Unger 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. PMID 32370572
  • Wong TY, Mitchell P. The eye in hypertension. Lancet. 2007 Feb 3;369(9559):425-35. doi: 10.1016/S0140-6736(07)60198-6. PMID 17276782
  • Kurniawan 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. PMID 22205607

Identifiers

NCT: NCT06098300 · OPHT-240323

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗