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Left Ventricular Fibrosis in Chronic Kidney Disease (FibroCKD)

This study is currently recruiting participants.
Verified June 2017 by Dr Manvir Kaur Hayer, University Hospital Birmingham NHS Foundation Trust
Sponsor:
ClinicalTrials.gov Identifier:
NCT03176862
First Posted: June 6, 2017
Last Update Posted: June 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
British Heart Foundation
Information provided by (Responsible Party):
Dr Manvir Kaur Hayer, University Hospital Birmingham NHS Foundation Trust
  Purpose
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.

Condition Intervention
Chronic Kidney Diseases Cardio-Renal Syndrome Myocardial Fibrosis Uraemic Cardiomyopathy Diagnostic Test: cardiac magnetic resonance scan Diagnostic Test: Cardiopulmonary exercise test with stress echocardiogram Diagnostic Test: 24-hour ECG holter monitor Diagnostic Test: 12-lead ECG Diagnostic Test: Cardiopulmonary exercise test Biological: Blood test

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Onset and Functional Consequences of Left Ventricular (LV) Fibrosis in Chronic Kidney

Resource links provided by NLM:


Further study details as provided by Dr Manvir Kaur Hayer, University Hospital Birmingham NHS Foundation Trust:

Primary Outcome Measures:
  • The effect of eGFR on heart muscle scarring (measured from cardiac MRI using T1 times). [ Time Frame: One baseline visit only ]
    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.


Secondary Outcome Measures:
  • The relationship between prolonged myocardial T1 and diastolic function. [ Time Frame: One baseline visit only ]
    The following diastolic function parameters will be measured on echocardiography: E/A, deceleration time and E/e'.

  • The relationship between prolonged myocardial T1 and effort tolerance. [ Time Frame: One baseline visit only ]
    The percent predicted peak oxygen uptake during exercise testing will be used as a surrogate marker of effort tolerance.

  • The effect of renal transplantation on myocardial fibrosis. [ Time Frame: Baseline visit (pre-operation), then follow up at 6 weeks and 1 year. ]
    Myocardial T1 times (cardiac MRI) and eGFR (blood testing) will best measured.


Biospecimen Retention:   Samples With DNA
Blood samples

Estimated Enrollment: 260
Actual Study Start Date: September 2015
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CKD
40 patients per group of CKD from stage 2 to stage 5.
Diagnostic Test: cardiac magnetic resonance scan
An MRI scan of the heart
Diagnostic Test: Cardiopulmonary exercise test with stress echocardiogram
An exercise bicycle test with echocardiogram done during the exercise.
Diagnostic Test: 24-hour ECG holter monitor
3 stickers attached to a small monitor are worn for 24 hours.
Diagnostic Test: 12-lead ECG
Can be done immediately by the bedside.
Biological: 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.
Diagnostic Test: cardiac magnetic resonance scan
An MRI scan of the heart
Diagnostic Test: 24-hour ECG holter monitor
3 stickers attached to a small monitor are worn for 24 hours.
Diagnostic Test: 12-lead ECG
Can be done immediately by the bedside.
Diagnostic Test: Cardiopulmonary exercise test
An exercise bicycle test. No stress echocardiogram.
Biological: 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.
Diagnostic Test: cardiac magnetic resonance scan
An MRI scan of the heart
Diagnostic Test: Cardiopulmonary exercise test with stress echocardiogram
An exercise bicycle test with echocardiogram done during the exercise.
Diagnostic Test: 12-lead ECG
Can be done immediately by the bedside.
Diagnostic Test: Cardiopulmonary exercise test
An exercise bicycle test. No stress echocardiogram.
Biological: Blood test
20 mls of blood will be taken to measure routine laboratory tests and biomarkers of fibrosis.

Detailed Description:

Aim and objectives:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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).
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176862


Contacts
Contact: Manvir K Hayer, MBChB 07812732857 manvir.hayer@uhb.nhs.uk
Contact: Jonathan N Townend, MD 01213712000

Locations
United Kingdom
University Hospital Birmingham Recruiting
Birmingham, West Midlands, United Kingdom, B15 2QT
Contact: Manvir K Hayer, MBChB    01213712000      
Contact: Jonathan N Townend, MD    01213712000      
Sponsors and Collaborators
Dr Manvir Kaur Hayer
British Heart Foundation
Investigators
Principal Investigator: Nicola C Edwards, PhD University Hospitals Birmingham NHS Foundation Trust
  More Information

Responsible Party: Dr Manvir Kaur Hayer, Clinical Research Fellow, University Hospital Birmingham NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03176862     History of Changes
Other Study ID Numbers: UHB
First Submitted: May 18, 2017
First Posted: June 6, 2017
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fibrosis
Kidney Diseases
Renal Insufficiency, Chronic
Cardiomyopathies
Cardio-Renal Syndrome
Pathologic Processes
Urologic Diseases
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Failure