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Идёт набор NCT06098300

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

— Наблюдательное Arterial Hypertension Blood Pressure, High

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Arterial Hypertension, Blood Pressure, High. Базовые параметры: 18 лет — 90 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Австрия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Change in retinal vessel density after achieving blood pressure treatment target (OCT-A). [Срок оценки: 12 weeks]
Вторичные конечные точки (7)
  • Change in choroidal vascularity index after achieving blood pressure treatment target (EDI-OCT). [Срок оценки: 12 weeks]
  • Change in neurovascular coupling after achieving blood pressure treatment target (DVA). [Срок оценки: 12 weeks]
  • Change in retinal oxygen saturation after achieving blood pressure treatment target (DVA). [Срок оценки: 12 weeks]
  • Change in ocular blood flow after achieving blood pressure treatment target (LSFG). [Срок оценки: 12 weeks]
  • Change in retinal oxygen extraction after achieving blood pressure treatment target. [Срок оценки: 12 weeks]
  • Change in ocular perfusion pressure and arterial blood pressure after achieving blood pressure treatment target. [Срок оценки: 12 weeks]
  • Change in retinal vessel diameter after achieving blood pressure treatment target (DVA). [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Австрия · 1 центр
  • Medical University of Vienna — Vienna

Публикации

  • 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

Идентификаторы

NCT: NCT06098300 · OPHT-240323

Первоисточники (государственные реестры)

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