Kidney Disease, ChronicCRIB-FLOWNCT04014127
Coronary Microvascular Dysfunction in Chronic Kidney Disease
An observational study of Kidney Disease, Chronic and Myocardial Dysfunction, run by University Hospital Birmingham NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Disease, Chronic, Myocardial Dysfunction
- What is being tested?
- Coronary flow reserve assessment, Sphygmocor and Electrocardiogram
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 May 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients attending University Hospitals Birmingham.
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Elizabeth Hospital
Birmingham, B15 2TH
Ashwin Radhakrishnan, BM MRCP, +447756931470, a.radhakrishnan@nhs.net
Jonathan N Townend, MD FRCP FESC
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Disease, Chronic, Myocardial Dysfunction
- Being tested
- Coronary flow reserve assessment, Sphygmocor, Electrocardiogram, Blood test, Urinary albumin/creatinine ratio
- Keywords
- coronary flow reserve, living kidney donation, peritoneal dialysis
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary flow reserve assessmentDiagnostic test
Coronary flow reserve will be assessed using Doppler transthoracic echocardiograpy and myocardial contrast echocardiography.
SphygmocorDiagnostic test
Pulse wave analysis and pulse wave velocity will be assessed using the Sphygmocor device
ElectrocardiogramDiagnostic test
An electrocardiogram will be performed prior to administration of adenosine to ensure no resting conduction disease
Blood testOther
Blood tests will be performed for markers of renal function, bone mineral metabolism and myocardial stretch and injury
Urinary albumin/creatinine ratioOther
Urine will be analysed for albumin/creatinine ratio
| Study group | Role | What they receive |
|---|---|---|
| Controls | 25 controls with preserved renal function Receives: Diagnostic Test: Coronary flow reserve assessment; Diagnostic Test: Sphygmocor; Diagnostic Test: Electrocardiogram; Other: Blood test; Other: Urinary albumin/creatinine ratio | |
| Kidney Donors | 25 living kidney donors who have donated a kidney at least 12 months prior to enrollment in the study. Receives: Diagnostic Test: Coronary flow reserve assessment; Diagnostic Test: Sphygmocor; Diagnostic Test: Electrocardiogram; Other: Blood test; Other: Urinary albumin/creatinine ratio | |
| Pre-dialysis | 25 patients with pre-dialysis chronic kidney disease stage 5 Receives: Diagnostic Test: Coronary flow reserve assessment; Diagnostic Test: Sphygmocor; Diagnostic Test: Electrocardiogram; Other: Blood test; Other: Urinary albumin/creatinine ratio | |
| Peritoneal dialysis | 25 patients with chronic kidney disease stage 5 undergoing peritoneal dialysis Receives: Diagnostic Test: Coronary flow reserve assessment; Diagnostic Test: Sphygmocor; Diagnostic Test: Electrocardiogram; Other: Blood test; Other: Urinary albumin/creatinine ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One baseline visit
Secondary outcomes (2)
Myocardial blood flow
Ultrasound measurement of myocardial blood flow using myocardial contrast echocardiography. Data will be presented as dB/sec
Measured: One baseline visit
Left ventricular ejection fraction
Echocardiogram assessed left ventricular ejection fraction by Simpson's biplane method. Data will be presented as %.
Measured: One baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start7 May 2019
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Disease, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Price, University Hospital Birmingham NHS Foundation Trust
- Investigators
- Jonathan N Townend, MD FRCP FESC, Principal investigator, University Hospitals Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014127
- Sponsor's protocol ID
- RRK6607
- Acronym
- CRIB-FLOW
- Status last verified
- Jul 2019
- First submitted
- 8 Jul 2019
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Microvascular Dysfunction in Chronic Kidney Disease: The Chronic Renal Impairment in Birmingham Coronary Flow Reserve (CRIB FLOW) Study
- ClinicalTrials.gov ID
- NCT04014127
- Acronym / sponsor ID
- CRIB-FLOW / RRK6607
- Conditions
- Kidney Disease, Chronic, Myocardial Dysfunction
- Keywords
- coronary flow reserve, living kidney donation, peritoneal dialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital Birmingham NHS Foundation TrustUniversity, hospital or other
- Study start
- 7 May 2019 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Controls | – | Diagnostic Test: Coronary flow reserve assessment, Diagnostic Test: Sphygmocor, Diagnostic Test: Electrocardiogram, Other: Blood test, Other: Urinary albumin/creatinine ratio25 controls with preserved renal function |
| Kidney Donors | – | Diagnostic Test: Coronary flow reserve assessment, Diagnostic Test: Sphygmocor, Diagnostic Test: Electrocardiogram, Other: Blood test, Other: Urinary albumin/creatinine ratio25 living kidney donors who have donated a kidney at least 12 months prior to enrollment in the study. |
| Pre-dialysis | – | Diagnostic Test: Coronary flow reserve assessment, Diagnostic Test: Sphygmocor, Diagnostic Test: Electrocardiogram, Other: Blood test, Other: Urinary albumin/creatinine ratio25 patients with pre-dialysis chronic kidney disease stage 5 |
| Peritoneal dialysis | – | Diagnostic Test: Coronary flow reserve assessment, Diagnostic Test: Sphygmocor, Diagnostic Test: Electrocardiogram, Other: Blood test, Other: Urinary albumin/creatinine ratio25 patients with chronic kidney disease stage 5 undergoing peritoneal dialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending University Hospitals Birmingham.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary flow reserve assessmentCoronary flow reserve will be assessed using Doppler transthoracic echocardiograpy and myocardial contrast echocardiography. | Diagnostic test | Controls, Kidney Donors, Peritoneal dialysis, Pre-dialysis |
| SphygmocorPulse wave analysis and pulse wave velocity will be assessed using the Sphygmocor device | Diagnostic test | Controls, Kidney Donors, Peritoneal dialysis, Pre-dialysis |
| ElectrocardiogramAn electrocardiogram will be performed prior to administration of adenosine to ensure no resting conduction disease | Diagnostic test | Controls, Kidney Donors, Peritoneal dialysis, Pre-dialysis |
| Blood testBlood tests will be performed for markers of renal function, bone mineral metabolism and myocardial stretch and injury | Other | Controls, Kidney Donors, Peritoneal dialysis, Pre-dialysis |
| Urinary albumin/creatinine ratioUrine will be analysed for albumin/creatinine ratio | Other | Controls, Kidney Donors, Peritoneal dialysis, Pre-dialysis |
Primary outcome
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
2 secondary outcomes
Myocardial blood flow
Time frame: One baseline visit
Left ventricular ejection fraction
Time frame: One baseline visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan N Townend, MD FRCP FESC principal investigator
University Hospitals Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Disease, Chronic and Myocardial Dysfunction, run by University Hospital Birmingham NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashwin Radhakrishnan, BM MRCP (+447756931470, a.radhakrishnan@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary flow reserve (time frame: One baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.