REWARD: Using the REtina as a Window To Detect Cardiac microvasculAR Dysfunction In Diabetes Mellitus

• Conditions: Retinopathy, Diabetic; Diastolic Dysfunction; Microalbuminuria
• Interventions: Diagnostic Test: Cardiac Assessments and Eye Assessments

• Registration Number: NCT04025996
• Lead Sponsor: National Heart Centre Singapore

Brief Summary

Retinopathy may be associated with diastolic dysfunction and/or coronary flow reserve in the heart, and albuminuria in diabetic patients. The objective of this study is to examine the cross-sectional relationships of retinopathy with indices of left ventricular diastolic function, coronary flow reserve and urinary albumin excretion, among diabetic patients.

Detailed Description

Diabetes is a potent risk factor for macrovascular coronary disease, leading to systolic dysfunction and heart failure. More recently diabetic microvascular disease has been recognized to play a key role in the development of diastolic dysfunction and heart failure with preserved ejection fraction. A new paradigm in diabetic heart disease centers on microvascular endothelial dysfunction involving the intra-myocardial capillaries and leading to cardiomyocyte dysfunction and diastolic dysfunction. This is analogous to the microvascular dysfunction well-described in the diabetic retinopathy and nephropathy. Yet, whereas diabetic retinal screening for retinopathy and screening for microalbuminuria are routine, diabetic cardiac screening for microvascular dysfunction is practically non-existent. The retinal vasculature may represent a window of opportunity to detect concurrent microvascular disease in the heart and kidneys before the onset of clinical symptoms. However, there are limited studies that directly attempt to correlate retinopathy to diastolic dysfunction and microalbuminuria. Hence this study aims to examine the cross-sectional relationships of retinopathy with indices of left ventricular diastolic function, coronary flow reserve and urinary albumin excretion, among diabetic patients.

Study Timeline

• Study Start: 2018-02-20
• Study First Submitted: 2018-04-04
• Study First Submitted QC: 2019-07-16
• Study First Posted: 2019-07-19
• Status Verified: 2020-09
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-03
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age greater than equal to 21 years old

Exclusion Criteria

• Known history of active eye lens or corneal opacity
• Known allergy to eye drops
• Kidney disease with estimated GFR < 60
• Pregnant or lactating women
• Asthmatic status of the moderate persistent and above categories
• Chronic obstructive pulmonary disease
• Thyroid dysfunction

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diseased Group	Cardiac Assessments and Eye Assessments	Patients with type 2 diabetic retinopathy and known cardiac dysfunction.

Primary Outcome Measures

Name	Time	Method
Eye Examination	1 day	Retinal photography on diabetic patients will be performed to identify those with retinopathy.
Cross-sectional analyses will be performed to look at the association between diabetic retinopathy with left ventricular diastolic function, coronary flow reserve and urinary albumin excretion.	2 days	These data will provide initial evidence of the mechanistic link between microvascular dysfunction in the eye, heart and kidneys among patients with diabetes.

Trial Locations

Locations (1)

National Heart Centre Singapore; 🇸🇬 Singapore, Singapore