Using retinal photographs to assess cardiovascular disease risk in heart failure patients
Official title: Validation of the Prognostic Impact of a Retinal Photograph-based Cardiovascular Disease Risk Stratification System in de Novo HFrEF
Run by Yonsei University · NCT06978998 · Data updated 2026-11-12
This study is testing if looking at retinal photographs can help predict the risk of heart problems in people who have recently been diagnosed with heart failure.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | December 10, 2024 |
| Main results expected | December 10, 2030 |
| Study ends | December 10, 2030 |
| Registry record updated | May 18, 2025 |
| Trial ID | NCT06978998 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 20 to 79 years with a left ventricular ejection fraction of 40% or less.
✕Probably not a fit
Patients with severe ophthalmologic conditions that prevent high-quality retinal imaging will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to validate a retinal photograph-based risk stratification system for patients with newly diagnosed heart failure with reduced ejection fraction (HFrEF). Eligible participants, aged 20 to 79, will be enrolled during outpatient visits or hospitalizations, and their demographic, clinical, and echocardiographic data will be collected over a follow-up period of at least five years. The study will utilize a pre-existing, validated algorithm to analyze retinal images and assess its prognostic impact on clinical outcomes in heart failure patients. Continuous consent will be obtained to ensure ethical compliance throughout the study duration.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive method for better risk stratification and management of heart failure patients.
How similar studies have gone: While the use of retinal imaging for cardiovascular risk assessment is gaining interest, this specific application in heart failure is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged between 20 and 79 years with a left ventricular ejection fraction of 40% or less (assessed by transthoracic echocardiography), who have provided written consent for participation, have the capability to consent voluntarily Exclusion Criteria: * Inability to obtain high-quality fundus photographs due to severe ophthalmologic conditions * Presence of extensive retinal diseases that significantly impair visualization of the retinal vasculature * Decline to provide informed consent for study participation, including: * Pregnant individuals * Individuals lacking decision-making capacity
Where it's running
-
Severance hospital
Seoul, South Korea Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.