Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04025996
Other study ID # 2017/2592
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04558450 - Covid-19 Effects on Arterial Stiffness and Vascular Aging (CARTESIAN) N/A
Recruiting NCT02499601 - CORolla® TAA for Heart Failure With Preserved Ejection Fraction (HFpEF) and Diastolic Dysfunction (DD) N/A
Completed NCT01775865 - Targeting Inflammation to Treat Cardiovascular Aging Phase 2
Terminated NCT01188369 - Effects of Levosimendan in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy Phase 4
Recruiting NCT05552521 - Diastolic Dysfunction in Septic Shock and Cardiomyopathy Genetic Variants
Recruiting NCT05438030 - Diastolic Function Assessment With Cardiac Magnetic Resonance Imaging N/A
Completed NCT04128735 - Diastolic Dysfunction in Morbidly Obese Patients Undergo Bariatric Surgery
Completed NCT00689819 - Pre-clinical Cardiac Dysfunction Among Asymptomatic Hypertensive Patients N/A
Recruiting NCT04149990 - Angiotensin-Neprilysin Inhibition in Diastolic Dysfunction After AMI Phase 2
Completed NCT03768752 - Diastolic Dysfunction and Interstitial Lung Edema in Septic Patients
Completed NCT02932436 - Effects of Empagliflozin on Left Ventricular Diastolic Function Compared to Usual Care in Type 2 Diabetics Phase 4
Recruiting NCT05847244 - The Effect of Addition of Metformin In Obese Non- Diabetic Patients With Heart Failure With Preserved Ejection Fraction Phase 2
Enrolling by invitation NCT04190420 - The Transition From Hypertension to Hypertensive Heart Disease and Heart Failure, the PREFERS Hypertension Study
Completed NCT04114474 - Pre-operative Focused Transthoracic Echocardiography for Prediction of Post-operative Cardiac Complications
Not yet recruiting NCT06131008 - Diastology-Guided Management of Decompensated Heart Failure N/A
Completed NCT03110614 - Diastolic Dysfunction and Pauci-inflammatory Acute Exacerbations of COPD
Not yet recruiting NCT02285309 - Perioperative Measurements of Diastolic Function in Cardiac Surgery N/A
Completed NCT01761318 - Effect of Liraglutide on Cardiovascular Endpoints in Diabetes Mellitus Type 2 Patients Phase 4
Completed NCT00907439 - Study of the Effect of Inhaled Anesthetics on Diastolic Heart Function Using a Doppler-derived Efficiency Index N/A
Completed NCT00804518 - Effect of Exercise on Heart Function in Healthy Elderly People N/A