RecruitingNCT06978998

Validation of the Prognostic Impact of a Retinal Photograph-based Cardiovascular Disease Risk Stratification System in de Novo HFrEF


Sponsor

Yonsei University

Enrollment

100 participants

Start Date

Dec 10, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

"Despite significant advances in pharmacologic and device-based therapies, heart failure (HF) remains a major public health burden, with persistently high rates of hospitalization, impaired quality of life, and excess mortality-often exceeding those of leading malignancies. Prognosis in HF is shaped by its underlying etiology: ischemic HF often responds to revascularization strategies, whereas non-ischemic HF, particularly due to idiopathic or genetic cardiomyopathies, demonstrates highly variable outcomes and limited responsiveness to guideline-directed medical therapy (GDMT). Although left ventricular reverse remodeling (LVRR) is associated with favorable outcomes, only 40-50% of non-ischemic HF patients achieve meaningful LVRR with GDMT alone. In this context of therapeutic uncertainty and prognostic heterogeneity, there is a critical need for novel, non-invasive risk stratification tools. Retinal imaging offers a unique advantage, enabling direct, in vivo visualization of systemic microvascular and neurovascular integrity. Prior work from our group has demonstrated that deep learning algorithms applied to retinal fundus photographs can estimate physiologic and metabolic markers-including CAC scores-and predict future cardiovascular events. The Reti-CVD scoring system, derived from these models, has been externally validated in independent populations. In the present study, we aim to evaluate the prognostic utility of the Reti-CVD model in a cohort of patients with newly diagnosed HF and reduced ejection fraction. Specifically, we will assess whether retinal-derived risk scores at baseline are associated with adverse clinical outcomes, including cardiovascular events and all-cause mortality, and whether prognostic performance varies according to HF etiology."


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is validating a new tool that uses photographs of the back of the eye (retinal images) to predict cardiovascular risk in people with heart failure whose hearts have reduced pumping function. The tool may one day allow quick, non-invasive heart risk assessment during an eye exam. **You may be eligible if...** - You are between 20 and 79 years old - You have been diagnosed with heart failure with a reduced ejection fraction (the heart pumps less than 40% of its blood with each beat), confirmed by an echocardiogram - You are able to give informed consent **You may NOT be eligible if...** - You have severe eye disease that prevents a clear retinal photograph - You have extensive retinal disease that obscures blood vessel imaging - You are pregnant - You are unable to make decisions for yourself - You decline to give consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Severance hospital

Seoul, South Korea

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NCT06978998


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