Retinopathy, DiabeticNCT04025996
REWARD: Using the REtina as a Window To Detect Cardiac microvasculAR Dysfunction In Diabetes Mellitus
An observational study of Retinopathy, Diabetic and Diastolic Dysfunction, run by National Heart Centre Singapore at 1 site in Singapore.
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… Read more about this study
- Who is it for?
- Ages 21 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinopathy, Diabetic, Diastolic Dysfunction, Microalbuminuria
- What is being tested?
- Cardiac Assessments and Eye Assessments
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- 20 Feb 2018to 31 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have known heart condition and type II diabetes.
Who may be able to join
- Age greater than equal to 21 years old
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National Heart Centre Singapore
Singapore, 169609
About this study
Official title: Using the REtina as a Window To Detect Cardiac microvasculAR Dysfunction In Diabetes Mellitus
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.
Read the 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.
- Being tested
- Cardiac Assessments and Eye Assessments
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Assessments and Eye AssessmentsDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Diseased Group | Patients with type 2 diabetic retinopathy and known cardiac dysfunction. Receives: Diagnostic Test: Cardiac Assessments and Eye Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye Examination
Retinal photography on diabetic patients will be performed to identify those with retinopathy.
Measured: 1 day
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.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start20 Feb 2018
- Primary completion31 May 2021 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Retinopathy, DiabeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore National Eye Centre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025996
- Sponsor's protocol ID
- 2017/2592
- Status last verified
- Sep 2020
- First submitted
- 4 Apr 2018
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26659133Wong 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. doi: 10.1001/jama.293.1.63.
PubMed 15632337Lam 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. doi: 10.1161/CIRCULATIONAHA.106.659763. Epub 2007 Apr 2.
PubMed 17404159Lam 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.
PubMed 21670229Teo 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.
PubMed 27070649
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the REtina as a Window To Detect Cardiac microvasculAR Dysfunction In Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04025996
- Acronym / sponsor ID
- 2017/2592
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Collaborators
- Singapore National Eye Centre
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diseased Group | – | Diagnostic Test: Cardiac Assessments and Eye AssessmentsPatients with type 2 diabetic retinopathy and known cardiac dysfunction. |
Who may qualify
- Ages
- 21 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have known heart condition and type II diabetes.
Key inclusion criteria (1 listed)
- Age greater than equal to 21 years old
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Assessments and Eye AssessmentsCardiac 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 | Diagnostic test | Diseased Group |
Primary outcome
Eye Examination
Time frame: 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.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Background: PubMed 26659133Phan 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.
- Background: PubMed 15632337Wong 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. doi: 10.1001/jama.293.1.63.
- Background: PubMed 17404159Lam 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. doi: 10.1161/CIRCULATIONAHA.106.659763. Epub 2007 Apr 2.
- Background: PubMed 21670229Lam 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.
- Background: PubMed 27070649Teo 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.
- Individual participant dataSharing planned: No
Related trials for Retinopathy, Diabetic
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
Recruiting
To Investigate the Feasibility and Acceptability of Trained Non-medical Professionals Performing Laser Treatment for Proliferative Diabetic Retinopathy (PDR), and the Potential Impact on Service Capacity. Assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists
Proliferative Diabetic Retinopathy (PDR)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinopathy, Diabetic and Diastolic Dysfunction, run by National Heart Centre Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thng Ai Ling Sandra (+65 6704 2279, sandra.thng.a.l@nhcs.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eye Examination (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04025996, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.