Heart FailureNCT06978998
Validation of the Prognostic Impact of a Retinal Photograph-based Cardiovascular Disease Risk Stratification System in de Novo HFrEF
An observational study of Heart Failure and Cardiomyopathies, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Failure, Cardiomyopathies, Retinal Photograph
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Dec 2024to 10 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Severance hospital
Seoul
Chan Joo Lee, +82-2-2228-8460, zanzu@yuhs.ac
About this study
"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."
Read the detailed description
"Study Methods
- Eligible participants will be approached during outpatient visits or hospitalization. The purpose and procedures of the study will be explained in detail, and informed consent will be obtained prior to data collection. Even after initial enrollment, participants will undergo continuous re-confirmation of consent at each subsequent visit.
- All data will be collected in accordance with clinical guideline of heart failure in Korea (published from KHFS). This includes demographic characteristics, clinical history, echocardiographic parameters, laboratory findings, and cardiovascular outcomes. These data will be documented in a dedicated case report form.
- Participants will undergo assessments during the first year following enrollment, with a target total follow-up duration of at least five years to evaluate long-term clinical outcomes.
- All study data will be stored on password-protected computers with restricted access. No personal identifiers will be included and only de-identified, coded data will be used for analysis to ensure data confidentiality. This study will not involve development or modification of a deep learning algorithm. Instead, we will apply a pre-existing, validated retinal-based cardiovascular risk classification algorithm to newly diagnosed heart failure patients. Prognostic analyses will be conducted to determine whether algorithm-derived risk stratification is associated with differences in clinical outcomes during follow-up."
- Conditions
- Heart Failure, Cardiomyopathies, Retinal Photograph, Deep Learning, Reti-CVD
- Medical subject headings
- Heart Failure, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| De novo Heart Failure cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to completion of follow up, up to 5 years
Secondary outcomes (1)
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).
Measured: At 6months and 12 months after GDMT initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start10 Dec 2024
- Primary completion10 Dec 2030 (estimated)
- Study completion10 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978998
- Sponsor's protocol ID
- 4-2024-1332
- Status last verified
- May 2025
- First submitted
- 11 May 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Prognostic Impact of a Retinal Photograph-based Cardiovascular Disease Risk Stratification System in de Novo HFrEF
- ClinicalTrials.gov ID
- NCT06978998
- Acronym / sponsor ID
- 4-2024-1332
- Conditions
- Heart Failure, Cardiomyopathies, Retinal Photograph, Deep Learning, Reti-CVD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 10 Dec 2030 (estimated)
- Study completion
- 10 Dec 2030 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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."
Detailed description
"Study Methods
- Eligible participants will be approached during outpatient visits or hospitalization. The purpose and procedures of the study will be explained in detail, and informed consent will be obtained prior to data collection. Even after initial enrollment, participants will undergo continuous re-confirmation of consent at each subsequent visit.
- All data will be collected in accordance with clinical guideline of heart failure in Korea (published from KHFS). This includes demographic characteristics, clinical history, echocardiographic parameters, laboratory findings, and cardiovascular outcomes. These data will be documented in a dedicated case report form.
- Participants will undergo assessments during the first year following enrollment, with a target total follow-up duration of at least five years to evaluate long-term clinical outcomes.
- All study data will be stored on password-protected computers with restricted access. No personal identifiers will be included and only de-identified, coded data will be used for analysis to ensure data confidentiality. This study will not involve development or modification of a deep learning algorithm. Instead, we will apply a pre-existing, validated retinal-based cardiovascular risk classification algorithm to newly diagnosed heart failure patients. Prognostic analyses will be conducted to determine whether algorithm-derived risk stratification is associated with differences in clinical outcomes during follow-up."
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| De novo Heart Failure cohort | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of adjudicated cardiovascular event
Time frame: From enrollment to completion of follow up, up to 5 years
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
1 secondary outcome
Prevalence of Left Ventricular Reverse Remodeling
Time frame: At 6months and 12 months after GDMT initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Cardiomyopathies, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adjudicated cardiovascular event (time frame: From enrollment to completion of follow up, up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.