Chronic Kidney DiseasesFibroCKDNCT03176862
Left Ventricular Fibrosis in Chronic Kidney Disease
An observational study of Chronic Kidney Diseases and Cardio-Renal Syndrome, run by Dr Manvir Kaur Hayer at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Cardio-Renal Syndrome, Myocardial Fibrosis
- What is being tested?
- cardiac magnetic resonance scan, Cardiopulmonary exercise test with stress echocardiogram and 24-hour ECG holter monitor
- How many people
- 260 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- >18 years old
- CKD stage 2, 3, 4 and 5
Who cannot join
- Pregnancy
- Ischaemic heart disease (angina, ACS)
- Cerebral vascular disease
- Peripheral vascular disease
- Renovascular disease
- Diabetes mellitus
Show all 9Show fewer
- Valvular heart disease (more than mild)
- Established diagnosis of heart failure
- Cannot have an MRI scan
Trial locations and contacts
1 site in 1 country.
Jonathan N Townend, MD contact
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospital Birmingham
Birmingham, West Midlands, B15 2QT
Manvir K Hayer, MBChB, 01213712000
Jonathan N Townend, MD, 01213712000
About this study
Official title: Onset and Functional Consequences of Left Ventricular (LV) Fibrosis in Chronic Kidney
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.
Read the detailed description
Aim and objectives:
The primary objective of this study is to test the following hypotheses:
- 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:
- 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
- Chronic Kidney Diseases, Cardio-Renal Syndrome, Myocardial Fibrosis, Uraemic Cardiomyopathy
- Being tested
- cardiac magnetic resonance scan, Cardiopulmonary exercise test with stress echocardiogram, 24-hour ECG holter monitor, 12-lead ECG, Cardiopulmonary exercise test
- Medical subject headings
- Renal Insufficiency, Chronic, Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac magnetic resonance scanDiagnostic test
An MRI scan of the heart
Cardiopulmonary exercise test with stress echocardiogramDiagnostic test
An exercise bicycle test with echocardiogram done during the exercise.
24-hour ECG holter monitorDiagnostic test
3 stickers attached to a small monitor are worn for 24 hours.
12-lead ECGDiagnostic test
Can be done immediately by the bedside.
Cardiopulmonary exercise testDiagnostic test
An exercise bicycle test. No stress echocardiogram.
Blood testBiological
20 mls of blood will be taken to measure routine laboratory tests and biomarkers of fibrosis.
| Study group | Role | What they receive |
|---|---|---|
| CKD | 40 patients per group of CKD from stage 2 to stage 5. Receives: 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; Biological: 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. Receives: Diagnostic Test: cardiac magnetic resonance scan; Diagnostic Test: 24-hour ECG holter monitor; Diagnostic Test: 12-lead ECG; Diagnostic Test: Cardiopulmonary exercise test; Biological: Blood test | |
| Controls | 40 healthy controls and 40 hypertensive controls. Receives: Diagnostic Test: cardiac magnetic resonance scan; Diagnostic Test: Cardiopulmonary exercise test with stress echocardiogram; Diagnostic Test: 12-lead ECG; Diagnostic Test: Cardiopulmonary exercise test; Biological: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One baseline visit only
Secondary outcomes (3)
The relationship between prolonged myocardial T1 and diastolic function.
The following diastolic function parameters will be measured on echocardiography: E/A, deceleration time and E/e'.
Measured: One baseline visit only
The relationship between prolonged myocardial T1 and effort tolerance.
The percent predicted peak oxygen uptake during exercise testing will be used as a surrogate marker of effort tolerance.
Measured: One baseline visit only
The effect of renal transplantation on myocardial fibrosis.
Myocardial T1 times (cardiac MRI) and eGFR (blood testing) will best measured.
Measured: Baseline visit (pre-operation), then follow up at 6 weeks and 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study startSep 2015
- Primary completionJul 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Manvir Kaur Hayer
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Responsible party
- Sponsor-investigator, Dr Manvir Kaur Hayer, University Hospital Birmingham NHS Foundation Trust
- Investigators
- Nicola C Edwards, PhD, Principal investigator, University Hospital Birmingham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176862
- Sponsor's protocol ID
- UHB
- Acronym
- FibroCKD
- Status last verified
- Jun 2017
- First submitted
- 18 May 2017
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32682713
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onset and Functional Consequences of Left Ventricular (LV) Fibrosis in Chronic Kidney
- ClinicalTrials.gov ID
- NCT03176862
- Acronym / sponsor ID
- FibroCKD / UHB
- Conditions
- Chronic Kidney Diseases, Cardio-Renal Syndrome, Myocardial Fibrosis, Uraemic Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Dr Manvir Kaur HayerUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- Sep 2015 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aim and objectives:
The primary objective of this study is to test the following hypotheses:
- 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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CKD | – | 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, Biological: Blood test40 patients per group of CKD from stage 2 to stage 5. |
| Kidney transplant recipients | – | Diagnostic Test: cardiac magnetic resonance scan, Diagnostic Test: 24-hour ECG holter monitor, Diagnostic Test: 12-lead ECG, Diagnostic Test: Cardiopulmonary exercise test, Biological: Blood test20 live-donor recipients will be studied pre-operatively and then followed up at 6 weeks and 1 years post-operatively. |
| Controls | – | Diagnostic Test: cardiac magnetic resonance scan, Diagnostic Test: Cardiopulmonary exercise test with stress echocardiogram, Diagnostic Test: 12-lead ECG, Diagnostic Test: Cardiopulmonary exercise test, Biological: Blood test40 healthy controls and 40 hypertensive controls. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- >18 years old
- CKD stage 2, 3, 4 and 5
Key exclusion criteria (9 listed)
- Pregnancy
- Ischaemic heart disease (angina, ACS)
- Cerebral vascular disease
- Peripheral vascular disease
- Renovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac magnetic resonance scanAn MRI scan of the heart | Diagnostic test | CKD, Controls, Kidney transplant recipients |
| Cardiopulmonary exercise test with stress echocardiogramAn exercise bicycle test with echocardiogram done during the exercise. | Diagnostic test | CKD, Controls |
| 24-hour ECG holter monitor3 stickers attached to a small monitor are worn for 24 hours. | Diagnostic test | CKD, Kidney transplant recipients |
| 12-lead ECGCan be done immediately by the bedside. | Diagnostic test | CKD, Controls, Kidney transplant recipients |
| Cardiopulmonary exercise testAn exercise bicycle test. No stress echocardiogram. | Diagnostic test | Controls, Kidney transplant recipients |
| Blood test20 mls of blood will be taken to measure routine laboratory tests and biomarkers of fibrosis. | Biological | CKD, Controls, Kidney transplant recipients |
Primary outcome
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.
3 secondary outcomes
The relationship between prolonged myocardial T1 and diastolic function.
Time frame: One baseline visit only
The relationship between prolonged myocardial T1 and effort tolerance.
Time frame: One baseline visit only
The effect of renal transplantation on myocardial fibrosis.
Time frame: Baseline visit (pre-operation), then follow up at 6 weeks and 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Derived from this study: PubMed 32682713Hayer 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan N Townend, MD contact
Nicola C Edwards, PhD principal investigator
University Hospital Birmingham NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Cardio-Renal Syndrome, run by Dr Manvir Kaur Hayer at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manvir K Hayer, MBChB (07812732857, manvir.hayer@uhb.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of eGFR on heart muscle scarring (measured from cardiac MRI using T1 times). (time frame: One baseline visit only). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03176862, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.