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

Diastolic Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04025996
• Other study ID #: 2017/2592
• Status: Recruiting
• Start date: February 20, 2018
• Est. completion date: May 31, 2021

Study information

• Verified date: September 2020
• Source: National Heart Centre Singapore
• Contact: Thng Ai Ling Sandra
• Phone: +65 6704 2279
• Email: sandra.thng.a.l[@]nhcs.com.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Retinopathy
• Diastolic Dysfunction
• Microalbuminuria
• Retinopathy, Diabetic

Intervention

Diagnostic Test:
• Cardiac Assessments and Eye Assessments
Cardiac Assessments, include the following: transthoracic echocardiography computed tomography of coronary arteries position emission tomography computed tomography or single photon emission tomography computed tomography Eye examinations, include the following: pupil dilation retinal photography dynamic vessel analyser IOL master

Locations

Country	Name	City	State
Singapore	National Heart Centre Singapore	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National Heart Centre Singapore	Singapore National Eye Centre

Country where clinical trial is conducted

Singapore, 

References & Publications (5)

Lam CS, Lyass A, Kraigher-Krainer E, Massaro JM, Lee DS, Ho JE, Levy D, Redfield MM, Pieske BM, Benjamin EJ, Vasan RS. Cardiac dysfunction and noncardiac dysfunction as precursors of heart failure with reduced and preserved ejection fraction in the community. Circulation. 2011 Jul 5;124(1):24-30. doi: 10.1161/CIRCULATIONAHA.110.979203. Epub 2011 Jun 13. Erratum in: Circulation. 2011 Oct 25;124(17):e458. — View Citation

Lam CS, Roger VL, Rodeheffer RJ, Bursi F, Borlaug BA, Ommen SR, Kass DA, Redfield MM. Cardiac structure and ventricular-vascular function in persons with heart failure and preserved ejection fraction from Olmsted County, Minnesota. Circulation. 2007 Apr 17;115(15):1982-90. Epub 2007 Apr 2. Erratum in: Circulation. 2007 May 22;115(20):e535. — View Citation

Phan K, Mitchell P, Liew G, Plant AJ, Wang SB, Au C, Chiha J, Kovoor P, Thiagalingam A, Burlutsky G, Gopinath B. Association between Retinal Arteriolar and Venule Calibre with Prevalent Heart Failure: A Cross-Sectional Study. PLoS One. 2015 Dec 11;10(12):e0144850. doi: 10.1371/journal.pone.0144850. eCollection 2015. — View Citation

Teo LY, Chan LL, Lam CS. Heart failure with preserved ejection fraction in hypertension. Curr Opin Cardiol. 2016 Jul;31(4):410-6. doi: 10.1097/HCO.0000000000000292. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eye Examination	Retinal photography on diabetic patients will be performed to identify those with retinopathy.	1 day
Primary	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.	These data will provide initial evidence of the mechanistic link between microvascular dysfunction in the eye, heart and kidneys among patients with diabetes.	2 days