Diastolic Dysfunction Clinical Trial
Official title:
Using the REtina as a Window To Detect Cardiac microvasculAR Dysfunction In Diabetes Mellitus
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Singapore | National Heart Centre Singapore | Singapore |
Lead Sponsor | Collaborator |
---|---|
National Heart Centre Singapore | Singapore National Eye Centre |
Singapore,
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
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 |
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