Novel Clinical Utility of Retinal Imaging in Patients With Heart Failure

Sponsor
The Cleveland Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05086978
Collaborator
(none)
250
Enrollment
1
Location
48
Anticipated Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Endothelial dysfunction and microvascular disease have been shown to play an important role in both the development and progression of heart failure. Retinal imaging provides a unique opportunity to non-invasively assess retinal microcirculation. Leveraging the non-invasiveness and relative ease of use of portable retinal imaging, we propose to investigate its clinical utility in assessing endothelial/microvascular dysfunction across the spectrum of heart failure. We aim to test the hypothesis that the degree of abnormality in retinal vessels is associated with heart failure disease severity, endothelial/microvascular dysfunction, and, potentially, treatment responses.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed Description

    This is a pilot human study to test the hypothesis that the degree of abnormality in retinal vessels is associated with heart failure disease severity, endothelial/microvascular dysfunction, and, potentially, treatment responses. Previous epidemiology studies have shown an association between ophthalmic measurements like retinal vessel caliber, retinal microvascular signs, and retinopathy diagnosed from conventional digitized retinal imaging, and the risk of heart failure, as well as alterations in left ventricular structure and function, and even altered filling pressure. Automatic detection software for retinal vessel caliber measurement is widely available, and deep learning algorithms have already enabled reliable detection of retinopathy from captured retinal images. The Zeiss® VisuScout 100 handheld retinal camera is commercially available and is already in clinical use at the Cleveland Clinic by Cole Eye Institute specialists for bedside consultations. However, the use of retinal imaging in risk stratifying cardiovascular diseases is unknown, in large part because routine capturing of these images at the point of care is not performed. Novel applications of this non-invasive screening strategy beyond routine ophthalmology-based evaluation may pave the way to scalable population health screening or disease monitoring initiatives. We have established laboratory procedures and equipment for all proposed biomarker evaluations and have published work supporting their mechanistic link to pathophysiologic processes.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Novel Clinical Utility of Retinal Imaging in Patients With Heart Failure: A Pilot Study
    Anticipated Study Start Date :
    Jan 1, 2022
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Jan 1, 2026

    Arms and Interventions

    ArmIntervention/Treatment
    Heart Failure out-patients

    Subjects with heart failure of any etiology

    Heart Failure in-patients

    Subjects with heart failure of any etiology

    Outcome Measures

    Primary Outcome Measures

    1. Retinal measurements and heart failure severity [2 years]

      To generate the methodologies and establish workflow, and to generate preliminary data to demonstrate the association of retinal measurements with heart failure disease severity.

    2. Retinal measurements and exercise capacity [2 years]

      To generate the methodologies and establish workflow, and to generate preliminary data to demonstrate the association of retinal measurements with exercise capacity represented by 6 Minute Walk Test distance

    Secondary Outcome Measures

    1. Blood analysis [2 years]

      Blood samples may be collected to assess for asymmetric dimethylarginine levels (ADMA, a surrogate of endothelial dysfunction)

    2. Urine analysis [2 years]

      Urine samples may be collected to obtain urine albumin/creatinine ratio (UACR) for microalbuminuria (a surrogate of microvascular disease)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 18 years or above; have been diagnosed with HF of any etiology or healthy control; able to provide informed consent and comply with study protocol; able to undergo retinal evaluation using a handheld, automated, non-mydriatric retinal camera; and able to provide written informed consent.
    Exclusion Criteria:
    • pregnancy or planned pregnancy; photosensitive epilepsy; significant ophthalmologic conditions such as cataract, glaucoma, blindness, or progressive diabetic retinopathy; having undergone retinal laser photocoagulation; any condition which, in the judgment of the investigator, would place a patient at undue risk by being enrolled in the trial, or cause inability to comply with the study.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Cleveland ClinicClevelandOhioUnited States44195

    Sponsors and Collaborators

    • The Cleveland Clinic

    Investigators

    • Principal Investigator: W. H. Wilson Tang, MD, The Cleveland Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Wilson Tang, Principal Investigator, The Cleveland Clinic
    ClinicalTrials.gov Identifier:
    NCT05086978
    Other Study ID Numbers:
    • 21-940
    First Posted:
    Oct 21, 2021
    Last Update Posted:
    Dec 3, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Wilson Tang, Principal Investigator, The Cleveland Clinic
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 3, 2021