Coronary Microvascular Dysfunction in Chronic Kidney Disease
- Conditions
- Myocardial DysfunctionKidney Disease, Chronic
- Interventions
- Diagnostic Test: Coronary flow reserve assessmentDiagnostic Test: SphygmocorDiagnostic Test: ElectrocardiogramOther: Blood testOther: Urinary albumin/creatinine ratio
- Registration Number
- NCT04014127
- Lead Sponsor
- University Hospital Birmingham NHS Foundation Trust
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Healthy control with normal renal function
- Living kidney donor who has donated >12 months prior to enrolment in study
- Chronic kidney disease stage 5 who are pre-dialysis or on peritoneal dialysis
- Able to provide written informed consent
- Pregnancy
- Known ischaemic heart disease
- Diabetes mellitus
- Uncontrolled hypertension
- Evidence of 2nd or 3rd degree AV block or sick sinus syndrome in absence of a pacemaker
- History of allergic/adverse reaction to adenosine or Sonovue
- History of long QT syndrome
- Severe hypotension
- Significant valvular heart disease
- Significant chronic obstructive pulmonary disease or asthma with bronchospasm
- Unstable angina not controlled with medication
- Concurrent use of dipyridamole
- Decompensated heart failure
- Poor echo acoustic windows
- Chronic kidney disease stage 5 on haemodialysis
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Controls Blood test 25 controls with preserved renal function Kidney Donors Coronary flow reserve assessment 25 living kidney donors who have donated a kidney at least 12 months prior to enrollment in the study. Kidney Donors Electrocardiogram 25 living kidney donors who have donated a kidney at least 12 months prior to enrollment in the study. Controls Coronary flow reserve assessment 25 controls with preserved renal function Pre-dialysis Sphygmocor 25 patients with pre-dialysis chronic kidney disease stage 5 Peritoneal dialysis Electrocardiogram 25 patients with chronic kidney disease stage 5 undergoing peritoneal dialysis Controls Sphygmocor 25 controls with preserved renal function Kidney Donors Sphygmocor 25 living kidney donors who have donated a kidney at least 12 months prior to enrollment in the study. Kidney Donors Urinary albumin/creatinine ratio 25 living kidney donors who have donated a kidney at least 12 months prior to enrollment in the study. Pre-dialysis Urinary albumin/creatinine ratio 25 patients with pre-dialysis chronic kidney disease stage 5 Peritoneal dialysis Coronary flow reserve assessment 25 patients with chronic kidney disease stage 5 undergoing peritoneal dialysis Pre-dialysis Coronary flow reserve assessment 25 patients with pre-dialysis chronic kidney disease stage 5 Peritoneal dialysis Urinary albumin/creatinine ratio 25 patients with chronic kidney disease stage 5 undergoing peritoneal dialysis Controls Electrocardiogram 25 controls with preserved renal function Controls Urinary albumin/creatinine ratio 25 controls with preserved renal function Kidney Donors Blood test 25 living kidney donors who have donated a kidney at least 12 months prior to enrollment in the study. Pre-dialysis Electrocardiogram 25 patients with pre-dialysis chronic kidney disease stage 5 Pre-dialysis Blood test 25 patients with pre-dialysis chronic kidney disease stage 5 Peritoneal dialysis Sphygmocor 25 patients with chronic kidney disease stage 5 undergoing peritoneal dialysis Peritoneal dialysis Blood test 25 patients with chronic kidney disease stage 5 undergoing peritoneal dialysis
- Primary Outcome Measures
Name Time Method Coronary flow reserve One baseline visit Ultrasound-assessed coronary flow reserve. Data will be presented as a ratio (no unit) between maximal mean hyperemia flow velocity and baseline velocity
- Secondary Outcome Measures
Name Time Method Myocardial blood flow One baseline visit Ultrasound measurement of myocardial blood flow using myocardial contrast echocardiography. Data will be presented as dB/sec
Left ventricular ejection fraction One baseline visit Echocardiogram assessed left ventricular ejection fraction by Simpson's biplane method. Data will be presented as %.
Trial Locations
- Locations (1)
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom