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

NCT06098300 | Recruiting DMC

• 1 other identifier: OPHT-240323
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (7)

• Change in choroidal vascularity index after achieving blood pressure treatment target (EDI-OCT).

  12 weeks

• Change in neurovascular coupling after achieving blood pressure treatment target (DVA).

  12 weeks

• Change in retinal oxygen saturation after achieving blood pressure treatment target (DVA).

  12 weeks

• Change in ocular blood flow after achieving blood pressure treatment target (LSFG).

  12 weeks

• Change in retinal oxygen extraction after achieving blood pressure treatment target.

  12 weeks

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

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Related Links

• Description: Medical University of Vienna, Department of Clinical Pharmacology

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Gerhard Garhöfer, Assoc. Prof. Priv. Doz. MD

CONTACT

01 40400 29880; klin-pharmakologie@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: October 24, 2023
• Study Start: September 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

AU (1)