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Coronary Microvascular Dysfunction in Chronic Kidney Disease

Coronary Microvascular Dysfunction in Chronic Kidney Disease: The Chronic Renal Impairment in Birmingham Coronary Flow Reserve (CRIB FLOW) Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04014127
Acronym
CRIB-FLOW
Enrollment
100
Registered
2019-07-10
Start date
2019-05-07
Completion date
2020-12-31
Last updated
2019-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Disease, Chronic, Myocardial Dysfunction

Keywords

coronary flow reserve, living kidney donation, peritoneal dialysis

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.

Interventions

DIAGNOSTIC_TESTCoronary flow reserve assessment

Coronary flow reserve will be assessed using Doppler transthoracic echocardiograpy and myocardial contrast echocardiography.

DIAGNOSTIC_TESTSphygmocor

Pulse wave analysis and pulse wave velocity will be assessed using the Sphygmocor device

DIAGNOSTIC_TESTElectrocardiogram

An electrocardiogram will be performed prior to administration of adenosine to ensure no resting conduction disease

OTHERBlood test

Blood tests will be performed for markers of renal function, bone mineral metabolism and myocardial stretch and injury

OTHERUrinary albumin/creatinine ratio

Urine will be analysed for albumin/creatinine ratio

Sponsors

University Hospital Birmingham NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Coronary flow reserveOne baseline visitUltrasound-assessed coronary flow reserve. Data will be presented as a ratio (no unit) between maximal mean hyperemia flow velocity and baseline velocity

Secondary

MeasureTime frameDescription
Myocardial blood flowOne baseline visitUltrasound measurement of myocardial blood flow using myocardial contrast echocardiography. Data will be presented as dB/sec
Left ventricular ejection fractionOne baseline visitEchocardiogram assessed left ventricular ejection fraction by Simpson's biplane method. Data will be presented as %.

Other

MeasureTime frameDescription
Pulse wave analysisOne baseline visitAugmentation index measured using the Sphygmocor device. Data will be presented as %.
Pulse wave velocityOne baseline visitPulse wave velocity measured using the Sphygmocor device. Data will be presented as m/s

Countries

United Kingdom

Contacts

Primary ContactAshwin Radhakrishnan, BM MRCP
a.radhakrishnan@nhs.net+447756931470

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026