Coronary Microvascular Dysfunction in Chronic Kidney Disease (CRIB-FLOW)
July 8, 2019 updated by: Anna Price, University Hospital Birmingham NHS Foundation Trust
Coronary Microvascular Dysfunction in Chronic Kidney Disease: The Chronic Renal Impairment in Birmingham Coronary Flow Reserve (CRIB FLOW) Study
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Birmingham, United Kingdom, B15 2TH
- Recruiting
- Queen Elizabeth Hospital
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Contact:
- Ashwin Radhakrishnan, BM MRCP
- Phone Number: +447756931470
- Email: a.radhakrishnan@nhs.net
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Principal Investigator:
- Jonathan N Townend, MD FRCP FESC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients attending University Hospitals Birmingham.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Controls
25 controls with preserved renal function
|
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
|
|
Kidney Donors
25 living kidney donors who have donated a kidney at least 12 months prior to enrollment in the study.
|
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
|
|
Pre-dialysis
25 patients with pre-dialysis chronic kidney disease stage 5
|
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
|
|
Peritoneal dialysis
25 patients with chronic kidney disease stage 5 undergoing peritoneal dialysis
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Coronary flow reserve
Time Frame: 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
|
One baseline visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Myocardial blood flow
Time Frame: One baseline visit
|
Ultrasound measurement of myocardial blood flow using myocardial contrast echocardiography.
Data will be presented as dB/sec
|
One baseline visit
|
|
Left ventricular ejection fraction
Time Frame: One baseline visit
|
Echocardiogram assessed left ventricular ejection fraction by Simpson's biplane method.
Data will be presented as %.
|
One baseline visit
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pulse wave analysis
Time Frame: One baseline visit
|
Augmentation index measured using the Sphygmocor device.
Data will be presented as %.
|
One baseline visit
|
|
Pulse wave velocity
Time Frame: One baseline visit
|
Pulse wave velocity measured using the Sphygmocor device.
Data will be presented as m/s
|
One baseline visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jonathan N Townend, MD FRCP FESC, University Hospitals Birmingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 7, 2019
Primary Completion (Anticipated)
August 31, 2020
Study Completion (Anticipated)
December 31, 2020
Study Registration Dates
First Submitted
July 8, 2019
First Submitted That Met QC Criteria
July 8, 2019
First Posted (Actual)
July 10, 2019
Study Record Updates
Last Update Posted (Actual)
July 10, 2019
Last Update Submitted That Met QC Criteria
July 8, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RRK6607
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.