Using retinal photographs to assess cardiovascular disease risk in heart failure patients
Validation of the Prognostic Impact of a Retinal Photograph-based Cardiovascular Disease Risk Stratification System in de Novo HFrEF
Yonsei University · NCT06978998
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Yonsei University (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06978998 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 20 to 79 years with a left ventricular ejection fraction of 40% or less.
Not a fit: Patients with severe ophthalmologic conditions that prevent high-quality retinal imaging will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Seoul
- Severance hospital — Seoul, South Korea (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Cardiomyopathies, Retinal Photograph, Deep Learning, Reti-CVD