Study Results
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Basic Information
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UNKNOWN
260 participants
OBSERVATIONAL
2015-09-30
2018-08-31
Brief Summary
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Detailed Description
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The primary objective of this study is to test the following hypotheses:
i) Patients with early stage chronic kidney disease (CKD) exhibit diffuse LV fibrosis manifest by prolonged native myocardial T1 times and expansion of the extracellular volume (ECV) measured on MRI with a graded relationship to eGFR (stage of CKD), independent of blood pressure and arterial stiffness.
The secondary research objectives are to test the following hypotheses:
i) Prolonged native myocardial T1 times are associated with impaired diastolic function, altered arterial-ventricular interaction and impaired effort tolerance.
ii) Prolonged T1 times correlate with increases in serum biomarkers of collagen turnover associated with myocardial fibrosis that could be used to risk stratify individuals and enable targeted, personalized clinical care.
iii) Renal transplantation results in a regression of myocardial fibrosis as measured by T1 mapping.
DESIGN:
A cross-sectional analysis of 40 patients in each stage 2-5 CKD will be undertaken. These individuals will only be studied once (at baseline). In addition to this, at least 20 patients will be studied who are about to undergo a kidney transplant. These individuals will be studied at baseline (around the time of surgery), at 6 weeks post-operatively, and then 1 year post-operatively to assess the effect on renal transplantation on myocardial fibrosis.
SUBJECTS:
Patients will be recruited from the clinics run by University Hospitals Birmingham NHS Foundation Trust (UHB) with stages 2, 3, 4 and 5 CKD defined using eGFR calculated with the 4-variable 'Modification of Diet in Renal Disease' (MDRD) equation, with a minimum of two consecutive tests at least 90 days apart. Forty patients will be recruited per group of CKD. All study subjects will undergo a cardiac MRI scan, a cardiopulmonary exercise tests with stress echocardiogram, a 24-hour ECG holter monitor, and blood tests.
CONTROLS:
Forty healthy control subjects and forty hypertensive control subjects will be studied. All patients will undergo the identical research protocol to the CKD subjects, except they will not have a stress echocardiogram or an ECG holter monitor.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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CKD
40 patients per group of CKD from stage 2 to stage 5.
cardiac magnetic resonance scan
An MRI scan of the heart
Cardiopulmonary exercise test with stress echocardiogram
An exercise bicycle test with echocardiogram done during the exercise.
24-hour ECG holter monitor
3 stickers attached to a small monitor are worn for 24 hours.
12-lead ECG
Can be done immediately by the bedside.
Blood test
20 mls of blood will be taken to measure routine laboratory tests and biomarkers of fibrosis.
Kidney transplant recipients
20 live-donor recipients will be studied pre-operatively and then followed up at 6 weeks and 1 years post-operatively.
cardiac magnetic resonance scan
An MRI scan of the heart
24-hour ECG holter monitor
3 stickers attached to a small monitor are worn for 24 hours.
12-lead ECG
Can be done immediately by the bedside.
Cardiopulmonary exercise test
An exercise bicycle test. No stress echocardiogram.
Blood test
20 mls of blood will be taken to measure routine laboratory tests and biomarkers of fibrosis.
Controls
40 healthy controls and 40 hypertensive controls.
cardiac magnetic resonance scan
An MRI scan of the heart
Cardiopulmonary exercise test with stress echocardiogram
An exercise bicycle test with echocardiogram done during the exercise.
12-lead ECG
Can be done immediately by the bedside.
Cardiopulmonary exercise test
An exercise bicycle test. No stress echocardiogram.
Blood test
20 mls of blood will be taken to measure routine laboratory tests and biomarkers of fibrosis.
Interventions
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cardiac magnetic resonance scan
An MRI scan of the heart
Cardiopulmonary exercise test with stress echocardiogram
An exercise bicycle test with echocardiogram done during the exercise.
24-hour ECG holter monitor
3 stickers attached to a small monitor are worn for 24 hours.
12-lead ECG
Can be done immediately by the bedside.
Cardiopulmonary exercise test
An exercise bicycle test. No stress echocardiogram.
Blood test
20 mls of blood will be taken to measure routine laboratory tests and biomarkers of fibrosis.
Eligibility Criteria
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Inclusion Criteria
* CKD stage 2, 3, 4 and 5
Exclusion Criteria
* 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
18 Years
100 Years
ALL
Yes
Sponsors
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British Heart Foundation
OTHER
Dr Manvir Kaur Hayer
OTHER
Responsible Party
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Dr Manvir Kaur Hayer
Clinical Research Fellow
Principal Investigators
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Nicola C Edwards, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Birmingham NHS Foundation Trust
Locations
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University Hospital Birmingham
Birmingham, West Midlands, United Kingdom
Countries
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Central Contacts
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Jonathan N Townend, MD
Role: CONTACT
Facility Contacts
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Manvir K Hayer, MBChB
Role: primary
Jonathan N Townend, MD
Role: backup
References
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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.
Other Identifiers
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UHB
Identifier Type: -
Identifier Source: org_study_id
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