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

S

Singapore Health Services (SingHealth)

Status

Unknown

Conditions

Diastolic Dysfunction
Microalbuminuria
Retinopathy, Diabetic

Treatments

Diagnostic Test: Cardiac Assessments and Eye Assessments

Study type

Observational

Funder types

Other

Identifiers

NCT04025996
2017/2592

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

21 to 120 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

60 participants in 1 patient group

Diseased Group
Description:
Patients with type 2 diabetic retinopathy and known cardiac dysfunction.
Treatment:
Diagnostic Test: Cardiac Assessments and Eye Assessments

Trial contacts and locations

1

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Central trial contact

Thng Ai Ling Sandra; Tan Ying Zhen Janice

Data sourced from clinicaltrials.gov

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