Novel Clinical Utility of Retinal Imaging in Patients With Heart Failure
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 Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Heart Failure out-patients Subjects with heart failure of any etiology |
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| Heart Failure in-patients Subjects with heart failure of any etiology |
Outcome Measures
Primary Outcome Measures
- 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.
- 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
- Blood analysis [2 years]
Blood samples may be collected to assess for asymmetric dimethylarginine levels (ADMA, a surrogate of endothelial dysfunction)
- 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
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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
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
- Chandra A, Seidelmann SB, Claggett BL, Klein BE, Klein R, Shah AM, Solomon SD. The association of retinal vessel calibres with heart failure and long-term alterations in cardiac structure and function: the Atherosclerosis Risk in Communities (ARIC) Study. Eur J Heart Fail. 2019 Oct;21(10):1207-1215. doi: 10.1002/ejhf.1564. Epub 2019 Aug 1.
- Cheung N, Bluemke DA, Klein R, Sharrett AR, Islam FM, Cotch MF, Klein BE, Criqui MH, Wong TY. Retinal arteriolar narrowing and left ventricular remodeling: the multi-ethnic study of atherosclerosis. J Am Coll Cardiol. 2007 Jul 3;50(1):48-55. Epub 2007 Jun 18.
- Chung YR, Park SJ, Moon KY, Choi SA, Lim HS, Park SW, Kim JH, Lee K. Diabetic retinopathy is associated with diastolic dysfunction in type 2 diabetic patients with non-ischemic dilated cardiomyopathy. Cardiovasc Diabetol. 2017 Jul 6;16(1):82. doi: 10.1186/s12933-017-0566-y.
- Goto I, Katsuki S, Ikui H, Kimoto K, Mimatsu T. Pathological studies on the intracerebral and retinal arteries in cerebrovascular and noncerebrovascular diseases. Stroke. 1975 May-Jun;6(3):263-9.
- Marti CN, Gheorghiade M, Kalogeropoulos AP, Georgiopoulou VV, Quyyumi AA, Butler J. Endothelial dysfunction, arterial stiffness, and heart failure. J Am Coll Cardiol. 2012 Oct 16;60(16):1455-69. doi: 10.1016/j.jacc.2011.11.082. Epub 2012 Sep 19. Review.
- Tanaka M, Fujiwara H, Onodera T, Wu DJ, Matsuda M, Hamashima Y, Kawai C. Quantitative analysis of narrowings of intramyocardial small arteries in normal hearts, hypertensive hearts, and hearts with hypertrophic cardiomyopathy. Circulation. 1987 Jun;75(6):1130-9.
- Wong TY, Rosamond W, Chang PP, Couper DJ, Sharrett AR, Hubbard LD, Folsom AR, Klein R. Retinopathy and risk of congestive heart failure. JAMA. 2005 Jan 5;293(1):63-9.
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