About this trial
"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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Pregnant individuals
Individuals lacking decision-making capacity
Trial population
Patients aged 20 to 79 years with newly diagnosed heart failure of any etiology and a left ventricular ejection fraction (LVEF) ≤40%, identified during routine outpatient visits or hospitalizations
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Occurrence of adjudicated cardiovascular event
Clinical events were defined to encompass cardiovascular-related death, myocardial infarction, rehospitalization due to heart failure, malignant ventricular arrhythmias, and other major adverse cardiac events. Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned follow up period, whichever was earlier
Secondary outcomes
Prevalence of Left Ventricular Reverse Remodeling
Left Ventricular Reverse Remodeling is characterized by an increase in left ventricular ejection fraction (LVEF) of more than 10% in heart failure patients with a baseline LVEF of 40% or less, or an increase in LVEF of more than 40% during follow-up, which is classified as heart failure with improved EF (HFimpEF).
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