Clinical trial NCT06098300: Effects of Change in Blood Pressure on Retinal Capillary Rarefaction in Patients With Arterial Hypertension
Official title: Effects of Change in Blood Pressure on Retinal Capillary Rarefaction in Patients With Arterial Hypertension - a Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

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

Primary outcomes:
measure: Change in retinal vessel density after achieving blood pressure treatment target (OCT-A).
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in choroidal vascularity index after achieving blood pressure treatment target (EDI-OCT).
timeFrame: 12 weeks
measure: Change in neurovascular coupling after achieving blood pressure treatment target (DVA).
timeFrame: 12 weeks
measure: Change in retinal oxygen saturation after achieving blood pressure treatment target (DVA).
timeFrame: 12 weeks
measure: Change in ocular blood flow after achieving blood pressure treatment target (LSFG).
timeFrame: 12 weeks
measure: Change in retinal oxygen extraction after achieving blood pressure treatment target.
timeFrame: 12 weeks
measure: Change in ocular perfusion pressure and arterial blood pressure after achieving blood pressure treatment target.
timeFrame: 12 weeks
measure: Change in retinal vessel diameter after achieving blood pressure treatment target (DVA).
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
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