Coronary Microvascular Dysfunction in Chronic Kidney Disease
NCT ID: NCT04014127
Last Updated: 2019-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2019-05-07
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Controls
25 controls with preserved renal function
Coronary flow reserve assessment
Coronary flow reserve will be assessed using Doppler transthoracic echocardiograpy and myocardial contrast echocardiography.
Sphygmocor
Pulse wave analysis and pulse wave velocity will be assessed using the Sphygmocor device
Electrocardiogram
An electrocardiogram will be performed prior to administration of adenosine to ensure no resting conduction disease
Blood test
Blood tests will be performed for markers of renal function, bone mineral metabolism and myocardial stretch and injury
Urinary albumin/creatinine ratio
Urine will be analysed for albumin/creatinine ratio
Kidney Donors
25 living kidney donors who have donated a kidney at least 12 months prior to enrollment in the study.
Coronary flow reserve assessment
Coronary flow reserve will be assessed using Doppler transthoracic echocardiograpy and myocardial contrast echocardiography.
Sphygmocor
Pulse wave analysis and pulse wave velocity will be assessed using the Sphygmocor device
Electrocardiogram
An electrocardiogram will be performed prior to administration of adenosine to ensure no resting conduction disease
Blood test
Blood tests will be performed for markers of renal function, bone mineral metabolism and myocardial stretch and injury
Urinary albumin/creatinine ratio
Urine will be analysed for albumin/creatinine ratio
Pre-dialysis
25 patients with pre-dialysis chronic kidney disease stage 5
Coronary flow reserve assessment
Coronary flow reserve will be assessed using Doppler transthoracic echocardiograpy and myocardial contrast echocardiography.
Sphygmocor
Pulse wave analysis and pulse wave velocity will be assessed using the Sphygmocor device
Electrocardiogram
An electrocardiogram will be performed prior to administration of adenosine to ensure no resting conduction disease
Blood test
Blood tests will be performed for markers of renal function, bone mineral metabolism and myocardial stretch and injury
Urinary albumin/creatinine ratio
Urine will be analysed for albumin/creatinine ratio
Peritoneal dialysis
25 patients with chronic kidney disease stage 5 undergoing peritoneal dialysis
Coronary flow reserve assessment
Coronary flow reserve will be assessed using Doppler transthoracic echocardiograpy and myocardial contrast echocardiography.
Sphygmocor
Pulse wave analysis and pulse wave velocity will be assessed using the Sphygmocor device
Electrocardiogram
An electrocardiogram will be performed prior to administration of adenosine to ensure no resting conduction disease
Blood test
Blood tests will be performed for markers of renal function, bone mineral metabolism and myocardial stretch and injury
Urinary albumin/creatinine ratio
Urine will be analysed for albumin/creatinine ratio
Interventions
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Coronary flow reserve assessment
Coronary flow reserve will be assessed using Doppler transthoracic echocardiograpy and myocardial contrast echocardiography.
Sphygmocor
Pulse wave analysis and pulse wave velocity will be assessed using the Sphygmocor device
Electrocardiogram
An electrocardiogram will be performed prior to administration of adenosine to ensure no resting conduction disease
Blood test
Blood tests will be performed for markers of renal function, bone mineral metabolism and myocardial stretch and injury
Urinary albumin/creatinine ratio
Urine will be analysed for albumin/creatinine ratio
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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University Hospital Birmingham NHS Foundation Trust
OTHER
Responsible Party
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Anna Price
Co-Investigator
Principal Investigators
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Jonathan N Townend, MD FRCP FESC
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Birmingham
Locations
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Queen Elizabeth Hospital
Birmingham, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RRK6607
Identifier Type: -
Identifier Source: org_study_id
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