Coronary Microvascular Dysfunction in Chronic Kidney Disease

NCT04014127 | Unknown

• 1 other identifier: RRK6607
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Disease, Chronic; Myocardial Dysfunction

Keywords

coronary flow reserve; living kidney donation; peritoneal dialysis

Outcome Measures

Primary Outcomes (1)

• 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

  One baseline visit

Secondary Outcomes (2)

• Myocardial blood flow

  One baseline visit

• Left ventricular ejection fraction

  One baseline visit

Other Outcomes (2)

• Pulse wave analysis

  One baseline visit

• Pulse wave velocity

  One baseline visit

Study Arms (4)

Controls

25 controls with preserved renal function

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.

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

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

Diagnostic Test: Coronary flow reserve assessment; Diagnostic Test: Sphygmocor; Diagnostic Test: Electrocardiogram; Other: Blood test; Other: Urinary albumin/creatinine ratio

Interventions

Coronary flow reserve assessment DIAGNOSTIC_TEST

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

Controls; Kidney Donors; Peritoneal dialysis; Pre-dialysis

Sphygmocor DIAGNOSTIC_TEST

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

Controls; Kidney Donors; Peritoneal dialysis; Pre-dialysis

Electrocardiogram DIAGNOSTIC_TEST

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

Controls; Kidney Donors; Peritoneal dialysis; Pre-dialysis

Blood test OTHER

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

Controls; Kidney Donors; Peritoneal dialysis; Pre-dialysis

Urinary albumin/creatinine ratio OTHER

Urine will be analysed for albumin/creatinine ratio

Controls; Kidney Donors; Peritoneal dialysis; Pre-dialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending University Hospitals Birmingham.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Birmingham NHS Foundation Trust: lead

Study Sites (1)

Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma will be stored for future biomarker analysis including N terminal pro brain natriuretic peptide and troponin.

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Electrocardiography; Hematologic Tests

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• Jonathan N Townend, MD FRCP FESC

  University Hospitals Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashwin Radhakrishnan, BM MRCP

CONTACT

+447756931470; a.radhakrishnan@nhs.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 10, 2019
• Study Start: May 7, 2019
• Primary Completion: August 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)