NCT03176862

Brief Summary

This study aims to understand the onset an functional consequences of left ventricular interstitial fibrosis in patients with chronic kidney disease (stage 2 to 5), as well as assess whether transplantation results in a regression of cardiac fibrosis.Thus all patients will undergo: 1) a cardiac magnetic resonance imaging (MRI) scan to assess cardiac function and measure left ventricular interstitial fibrosis; 2) a cardiopulmonary stress echocardiogram to understand the functional consequences of fibrosis and rule out any underlying ischaemic heart disease; 3) a 24 hour holter monitor and electrocardiogram (ECG) to assess whether these patients are at higher risk of arrhythmia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

2.8 years

First QC Date

May 18, 2017

Last Update Submit

June 5, 2017

Conditions

Chronic Kidney DiseasesCardio-Renal SyndromeMyocardial FibrosisUraemic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • The effect of eGFR on heart muscle scarring (measured from cardiac MRI using T1 times).

    eGFR is a measurement of kidney function. Heart muscle scarring levels can be derived from cardiac MRI using a technique called T1 mapping. T1 maps of the heart will be acquired using cardiac MRI. eGFR will be measured from a blood tests, using the MDRD equation. The relationship between the measured T1 times and eGFR will be analysed using statistical tests.

    One baseline visit only

Secondary Outcomes (3)

  • The relationship between prolonged myocardial T1 and diastolic function.

    One baseline visit only

  • The relationship between prolonged myocardial T1 and effort tolerance.

    One baseline visit only

  • The effect of renal transplantation on myocardial fibrosis.

    Baseline visit (pre-operation), then follow up at 6 weeks and 1 year.

Study Arms (3)

CKD

40 patients per group of CKD from stage 2 to stage 5.

Diagnostic Test: cardiac magnetic resonance scanDiagnostic Test: Cardiopulmonary exercise test with stress echocardiogramDiagnostic Test: 24-hour ECG holter monitorDiagnostic Test: 12-lead ECGBiological: Blood test

Kidney transplant recipients

20 live-donor recipients will be studied pre-operatively and then followed up at 6 weeks and 1 years post-operatively.

Diagnostic Test: cardiac magnetic resonance scanDiagnostic Test: 24-hour ECG holter monitorDiagnostic Test: 12-lead ECGDiagnostic Test: Cardiopulmonary exercise testBiological: Blood test

Controls

40 healthy controls and 40 hypertensive controls.

Diagnostic Test: cardiac magnetic resonance scanDiagnostic Test: Cardiopulmonary exercise test with stress echocardiogramDiagnostic Test: 12-lead ECGDiagnostic Test: Cardiopulmonary exercise testBiological: Blood test

Interventions

cardiac magnetic resonance scanDIAGNOSTIC_TEST

An MRI scan of the heart

CKDControlsKidney transplant recipients
Cardiopulmonary exercise test with stress echocardiogramDIAGNOSTIC_TEST

An exercise bicycle test with echocardiogram done during the exercise.

CKDControls
24-hour ECG holter monitorDIAGNOSTIC_TEST

3 stickers attached to a small monitor are worn for 24 hours.

CKDKidney transplant recipients
12-lead ECGDIAGNOSTIC_TEST

Can be done immediately by the bedside.

CKDControlsKidney transplant recipients
Cardiopulmonary exercise testDIAGNOSTIC_TEST

An exercise bicycle test. No stress echocardiogram.

ControlsKidney transplant recipients
Blood testBIOLOGICAL

20 mls of blood will be taken to measure routine laboratory tests and biomarkers of fibrosis.

CKDControlsKidney transplant recipients

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stable CKD from early to severe late stage (stage 2 to 5). Patients expected to undergo live-donor kidney transplantation. Healthy controls. Hypertensive controls (stable, well controlled hypertension).

You may qualify if:

  • \>18 years old
  • CKD stage 2, 3, 4 and 5

You may not qualify if:

  • Pregnancy
  • Ischaemic heart disease (angina, ACS)
  • Cerebral vascular disease
  • Peripheral vascular disease
  • Renovascular disease
  • Diabetes mellitus
  • Valvular heart disease (more than mild)
  • Established diagnosis of heart failure
  • Cannot have an MRI scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Birmingham

Birmingham, West Midlands, B15 2QT, United Kingdom

RECRUITING

Related Publications (1)

  • Hayer MK, Radhakrishnan A, Price AM, Liu B, Baig S, Weston CJ, Biasiolli L, Ferro CJ, Townend JN, Steeds RP, Edwards NC; Birmingham Cardio-Renal Group. Defining Myocardial Abnormalities Across the Stages of Chronic Kidney Disease: A Cardiac Magnetic Resonance Imaging Study. JACC Cardiovasc Imaging. 2020 Nov;13(11):2357-2367. doi: 10.1016/j.jcmg.2020.04.021. Epub 2020 Jul 15.

    PMID: 32682713DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Renal Insufficiency, ChronicCardio-Renal Syndrome

Interventions

Exercise TestEchocardiography, StressElectrocardiographyHematologic Tests

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart FailureHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative TechniquesEchocardiographyCardiac Imaging TechniquesDiagnostic ImagingUltrasonographyElectrodiagnosisClinical Laboratory Techniques

Study Officials

  • Nicola C Edwards, PhD

    University Hospital Birmingham NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manvir K Hayer, MBChB

CONTACT

07812732857manvir.hayer@uhb.nhs.uk

Jonathan N Townend, MD

CONTACT

01213712000

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Research Fellow

Study Record Dates

First Submitted

May 18, 2017

First Posted

June 6, 2017

Study Start

September 1, 2015

Primary Completion

July 1, 2018

Study Completion

August 1, 2018

Last Updated

June 6, 2017

Record last verified: 2017-06

Locations

GB(1)