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

NCT06978998 | Recruiting DMC

• 1 other identifier: 4-2024-1332
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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."

Conditions

Heart Failure; Cardiomyopathies; Retinal Photograph; Deep Learning; Reti-CVD

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment to completion of follow up, up to 5 years

Secondary Outcomes (1)

• Prevalence of Left Ventricular Reverse Remodeling

  At 6months and 12 months after GDMT initiation

Study Arms (1)

De novo Heart Failure cohort

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Heart Failure; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 18, 2025
• Study Start: December 10, 2024
• Primary Completion (Estimated): December 10, 2030
• Study Completion (Estimated): December 10, 2030
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)