An observational study in Kidney Disease, Chronic and Myocardial Dysfunction, sponsored by University Hospital Birmingham NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-10.
Sponsored by University Hospital Birmingham NHS Foundation Trust · Observational
This is an observational study assessing coronary microvascular function in healthy controls with normal kidney function, living kidney donors, pre-dialysis patients with chronic kidney disease stage 5 and patients on peritoneal dialysis.
The clinical syndrome of uraemic cardiomyopathy is prevalent in end stage renal disease and is associated with pathological cardiovascular changes including left ventricular hypertrophy, diastolic dysfunction and diffuse interstitial fibrosis. These combine to confer an elevated cardiovascular risk, including an increased risk of sudden cardiac death.
The cause of this increased cardiovascular risk is not clear but it is thought that coronary microvascular dysfunction may play a role. Coronary microvascular dysfunction is prevalent in many myocardial disease states, such as hypertrophic cardiomyopathy and heart failure with preserved ejection fraction, that share pathological similarities with uraemic cardiomyopathy.
Coronary flow reserve, a marker of coronary microvascular function, can be assessed non-invasively using echocardiography techniques. Previous studies have shown a reduction in coronary flow reserve in patients with chronic kidney disease. However, it is not clear if kidney donors - individuals who have a reduced kidney function but do not have progressive kidney disease - also demonstrate microvascular dysfunction. Similarly, although there is some evidence that patients on dialysis have improved coronary flow reserve compared to patients with pre-dialysis chronic kidney disease stage 5, there has been limited investigation into the role of peritoneal dialysis on coronary flow reserve.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 100 is below the median of 192 across 1,033 observational studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →University Hospital Birmingham NHS Foundation Trust is the lead sponsor of 35 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients attending University Hospitals Birmingham.
Exclusion Criteria:
25 controls with preserved renal function
Diagnostic Test: Coronary flow reserve assessment · Diagnostic Test: Sphygmocor · Diagnostic Test: Electrocardiogram · Other: Blood test · Other: Urinary albumin/creatinine ratio
25 living kidney donors who have donated a kidney at least 12 months prior to enrollment in the study.
Diagnostic Test: Coronary flow reserve assessment · Diagnostic Test: Sphygmocor · Diagnostic Test: Electrocardiogram · Other: Blood test · Other: Urinary albumin/creatinine ratio
25 patients with pre-dialysis chronic kidney disease stage 5
Diagnostic Test: Coronary flow reserve assessment · Diagnostic Test: Sphygmocor · Diagnostic Test: Electrocardiogram · Other: Blood test · Other: Urinary albumin/creatinine ratio
25 patients with chronic kidney disease stage 5 undergoing peritoneal dialysis
Diagnostic Test: Coronary flow reserve assessment · Diagnostic Test: Sphygmocor · Diagnostic Test: Electrocardiogram · Other: Blood test · Other: Urinary albumin/creatinine ratio
Coronary flow reserve will be assessed using Doppler transthoracic echocardiograpy and myocardial contrast echocardiography.
Pulse wave analysis and pulse wave velocity will be assessed using the Sphygmocor device
An electrocardiogram will be performed prior to administration of adenosine to ensure no resting conduction disease
Blood tests will be performed for markers of renal function, bone mineral metabolism and myocardial stretch and injury
Urine will be analysed for albumin/creatinine ratio
Coronary flow reserve
Ultrasound-assessed coronary flow reserve. Data will be presented as a ratio (no unit) between maximal mean hyperemia flow velocity and baseline velocity
Time frame: One baseline visit
Myocardial blood flow
Ultrasound measurement of myocardial blood flow using myocardial contrast echocardiography. Data will be presented as dB/sec
Time frame: One baseline visit
Left ventricular ejection fraction
Echocardiogram assessed left ventricular ejection fraction by Simpson's biplane method. Data will be presented as %.
Time frame: One baseline visit
Pulse wave analysis
Augmentation index measured using the Sphygmocor device. Data will be presented as %.
Time frame: One baseline visit
Pulse wave velocity
Pulse wave velocity measured using the Sphygmocor device. Data will be presented as m/s
Time frame: One baseline visit
Plan to share: No
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This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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University Hospital Birmingham NHS Foundation Trust