Condition or disease | Intervention/treatment |
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Kidney Disease, Chronic Myocardial Dysfunction | Diagnostic Test: Coronary flow reserve assessment Diagnostic Test: Sphygmocor Diagnostic Test: Electrocardiogram Other: Blood test Other: Urinary albumin/creatinine ratio |
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 |
Estimated Enrollment : | 100 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | Coronary Microvascular Dysfunction in Chronic Kidney Disease: The Chronic Renal Impairment in Birmingham Coronary Flow Reserve (CRIB FLOW) Study |
Actual Study Start Date : | May 7, 2019 |
Estimated Primary Completion Date : | August 31, 2020 |
Estimated Study Completion Date : | December 31, 2020 |
Group/Cohort | Intervention/treatment |
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Controls
25 controls with preserved renal function
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Diagnostic Test: Coronary flow reserve assessment
Coronary flow reserve will be assessed using Doppler transthoracic echocardiograpy and myocardial contrast echocardiography.
Diagnostic Test: Sphygmocor Pulse wave analysis and pulse wave velocity will be assessed using the Sphygmocor device
Diagnostic Test: Electrocardiogram An electrocardiogram will be performed prior to administration of adenosine to ensure no resting conduction disease
Other: Blood test Blood tests will be performed for markers of renal function, bone mineral metabolism and myocardial stretch and injury
Other: Urinary albumin/creatinine ratio Urine will be analysed for albumin/creatinine ratio
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Kidney Donors
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
Coronary flow reserve will be assessed using Doppler transthoracic echocardiograpy and myocardial contrast echocardiography.
Diagnostic Test: Sphygmocor Pulse wave analysis and pulse wave velocity will be assessed using the Sphygmocor device
Diagnostic Test: Electrocardiogram An electrocardiogram will be performed prior to administration of adenosine to ensure no resting conduction disease
Other: Blood test Blood tests will be performed for markers of renal function, bone mineral metabolism and myocardial stretch and injury
Other: Urinary albumin/creatinine ratio Urine will be analysed for albumin/creatinine ratio
|
Pre-dialysis
25 patients with pre-dialysis chronic kidney disease stage 5
|
Diagnostic Test: Coronary flow reserve assessment
Coronary flow reserve will be assessed using Doppler transthoracic echocardiograpy and myocardial contrast echocardiography.
Diagnostic Test: Sphygmocor Pulse wave analysis and pulse wave velocity will be assessed using the Sphygmocor device
Diagnostic Test: Electrocardiogram An electrocardiogram will be performed prior to administration of adenosine to ensure no resting conduction disease
Other: Blood test Blood tests will be performed for markers of renal function, bone mineral metabolism and myocardial stretch and injury
Other: 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
|
Diagnostic Test: Coronary flow reserve assessment
Coronary flow reserve will be assessed using Doppler transthoracic echocardiograpy and myocardial contrast echocardiography.
Diagnostic Test: Sphygmocor Pulse wave analysis and pulse wave velocity will be assessed using the Sphygmocor device
Diagnostic Test: Electrocardiogram An electrocardiogram will be performed prior to administration of adenosine to ensure no resting conduction disease
Other: Blood test Blood tests will be performed for markers of renal function, bone mineral metabolism and myocardial stretch and injury
Other: Urinary albumin/creatinine ratio Urine will be analysed for albumin/creatinine ratio
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ashwin Radhakrishnan, BM MRCP | +447756931470 | a.radhakrishnan@nhs.net |
United Kingdom | |
Queen Elizabeth Hospital | Recruiting |
Birmingham, United Kingdom, B15 2TH | |
Contact: Ashwin Radhakrishnan, BM MRCP +447756931470 a.radhakrishnan@nhs.net | |
Principal Investigator: Jonathan N Townend, MD FRCP FESC |
Principal Investigator: | Jonathan N Townend, MD FRCP FESC | University Hospitals Birmingham |
Tracking Information | |||||
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First Submitted Date | July 8, 2019 | ||||
First Posted Date | July 10, 2019 | ||||
Last Update Posted Date | July 10, 2019 | ||||
Actual Study Start Date | May 7, 2019 | ||||
Estimated Primary Completion Date | August 31, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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
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Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title | Coronary Microvascular Dysfunction in Chronic Kidney Disease | ||||
Official Title | Coronary Microvascular Dysfunction in Chronic Kidney Disease: The Chronic Renal Impairment in Birmingham Coronary Flow Reserve (CRIB FLOW) Study | ||||
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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Other Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples Without DNA Description:
Serum and plasma will be stored for future biomarker analysis including N terminal pro brain natriuretic peptide and troponin.
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Sampling Method | Non-Probability Sample | ||||
Study Population | Patients attending University Hospitals Birmingham. | ||||
Condition |
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Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
100 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | December 31, 2020 | ||||
Estimated Primary Completion Date | August 31, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts |
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Listed Location Countries | United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04014127 | ||||
Other Study ID Numbers | RRK6607 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Anna Price, University Hospital Birmingham NHS Foundation Trust | ||||
Study Sponsor | University Hospital Birmingham NHS Foundation Trust | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | University Hospital Birmingham NHS Foundation Trust | ||||
Verification Date | July 2019 |