Myocardial FibrosisCM3NCT03857633
MRI Assessment of Myocardial Fibrosis Associated With Monocyte Phenotype in End Stage Renal Failure
An observational study of Myocardial Fibrosis and End Stage Renal Failure on Dialysis, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Firstly, this study aims to understand how cardiac fibrosis mediated by inflammatory microvascular disease evolves during advanced chronic kidney disease and end stage renal failure and importantly how this changes with commencement on renal replacement therapy (haemodialysis and peritoneal dialysis) using sequential… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Fibrosis, End Stage Renal Failure on Dialysis, Chronic Kidney Disease, Stage IV (Severe)
- What is being tested?
- Cardiac MRI 1 - With Gadolinium Contrast, Cardiac MRI 2 - With Gadolinium Contrast and Cardiac MRI 3 - Without Gadolinium Contrast
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2019to 1 Feb 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced and progressive Chronic Kidney Disease (Stage 4/5) - under low clearance follow-up who are expected to start renal replacement therapy (either haemodialysis or peritoneal dialysis) within 6 months.
Who may be able to join
- Patients with a diagnosis of Chronic Kidney Disease stage 4 and above
- Patients with a progressive decline in renal function with a expectation to require future renal replacement therapy or currently on renal replacement therapy (Haemodialysis or Peritoneal Dialysis)
- Exclusion of macrovascular cardiac disease within the last 3 years
- Access for haemodialysis planned via tunnelled central venous catheter
Who cannot join
- Age under eighteen
- Patients with a diagnosis of Diabetes Mellitus
- Untreated macrovascular cardiac disease or Acute Coronary syndrome within 6 months of recruitment
- Previous or current treatment with immunosuppressive/modulatory therapy
- Current Malignancy
- Current use of Metformin
Show all 12Show fewer
- Pregnancy
- Contraindication to MRI Imaging
- Patients lacking capacity or unable to consent and non-English language speakers
- Immediate modality switch after commencement on renal replacement therapy i.e. transplantation
- Plan for treatment centre change/move outside of Imperial College Healthcare NHS Trust following commencement on renal replacement therapy
- Patients currently participating in an active CTIMP trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Process of Inflammation in the Development of Myocardial Fibrosis in Chronic Kidney Disease and End Stage Renal Failure - A Longitudinal Cohort Study Assessing Myocardial Fibrosis Development Using Cardiac MRI Correlated With Monocyte and Biochemical Profile Analysis During Transition to Renal Replacement Therapy
Firstly, this study aims to understand how cardiac fibrosis mediated by inflammatory microvascular disease evolves during advanced chronic kidney disease and end stage renal failure and importantly how this changes with commencement on renal replacement therapy (haemodialysis and peritoneal dialysis) using sequential cardiac MRI imaging. This method of imaging is non-invasive, provides significantly more data than echocardiography, is reproducible and accurate, has been validated in numerous studies and does not involve exposure to ionising radiation.
Secondly, this study aims to examine the changes in monocyte subsets and biochemical profile in peripheral blood prior to, during and after commencement on renal replacement therapy.
The investigators hypothesis would be that renal failure causes alteration in monocyte subset phenotype resulting in increased circulating inflammatory monocytes (human CD14high CD16high), initiating pro-inflammatory cytokine expression and thereby accelerating inflammatory cardiovascular disease and development of myocardial fibrosis.
Read the detailed description
There is significant excess of cardiac mortality in patients with end stage renal failure (ESRF) - 15 to 20% relative increased risk of cardiac death compared to the normal population. 20-30% of patients on renal replacement therapy (RRT) die from a cardiac cause (UK Renal Registry Data, 2016). However, only 30% have macrovascular disease at the time of autopsy. There is therefore a significant component of cardiac morbidity and mortality in this population that is mediated by microvascular disease and cardiac fibrosis. This includes abnormal myocardial remodelling, increased ventricular stiffness and ventricular hypertrophy, with development of arrhythmia and cardiac failure as well as increased atherosclerotic disease burden. Renal replacement therapy in itself also induces a pro-inflammatory response in patients increasing cardiac risk and there is poor understanding as to how to mediate this risk.
There is a lack of evidence in how to manage both patients and the RRT process to minimise the risk of patients developing cardiac disease. The mechanisms underlying this enhanced risk are not fully understood nor explained by traditional cardiovascular risk factors. The investigators propose to study the mechanism by which this might be mediated.
The investigators have previously reported alterations in monocyte subset populations in CKD patients that importantly predict CVD events. Furthermore, the investigators have shown that dyslipidaemia influences monocyte/macrophage phenotypes. The investigators propose an important interaction exists between chronic inflammation in the uraemic state, dyslipidaemia and the formation of deleterious monocyte/macrophage phenotypes that accelerates atherosclerosis. Cardiac MRI has been used in recent years to accurately assess the degree of cardiac fibrosis in end stage renal failure.
This clinical study builds on previous clinical and non-clinical studies at Imperial College London by unifying basic science, animal models and imaging studies into the clinical context of end stage renal failure. Increased understanding of the changes in cardiac function related to development of end stage renal failure and commencement on renal replacement therapy will provide significant and novel opportunities to optimise the management of patients in the pre-dialysis setting and prevent cardiovascular complications caused by long term renal replacement therapy.
This clinical observational study will involve the recruitment of 30 participants from general nephrology services at Imperial College Healthcare NHS Trust at CKD stage 4/5 with progressive decline in renal function (anticipated start on renal replacement therapy within 6 months). Participants will be divided into two cohorts of haemodialysis and peritoneal dialysis to enable comparison between the renal replacement modalities. As part of participants recruitment they will undergo comprehensive medical assessment and will remain under the follow-up of the renal team at frequent intervals.
Enrolled participants will undergo cardiac MRI imaging at three time points - First when initially recruited at CKD4/5, second at the point of commencement on renal replacement therapy (~6 months) and third after a further 6 months on renal replacement therapy. MRI results will be analysed at these time points for development of fibrotic and function change.
In partnership with MRI imaging patients will have blood samples collected at the same time intervals for analysis of blood count, biochemical markers, monocyte and lipid phenotypes.
- Conditions
- Myocardial Fibrosis, End Stage Renal Failure on Dialysis, Chronic Kidney Disease, Stage IV (Severe), Chronic Kidney Disease Stage V, Heart Failure
- Being tested
- Cardiac MRI 1 - With Gadolinium Contrast, Cardiac MRI 2 - With Gadolinium Contrast, Cardiac MRI 3 - Without Gadolinium Contrast, Cardiac MRI 3 - With Gadolinium Contrast, Peripheral Whole Blood Samples
- Keywords
- Cardiac MRI, Myocardial Fibrosis, End Stage Renal Failure, Monocyte Subsets, Renal Replacement Therapy
- Medical subject headings
- Renal Insufficiency, Chronic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRI 1 - With Gadolinium ContrastDiagnostic test
Cines for cardiac function and volumes, T2 myomaps, Resting perfusion and strain analysis, Tagging (strain), T1 myomaps, Late gadolinium enhancement
During the MRI scan participants would be required perform a short period of low intensity exercise involving peddling on an adapted cycle for 10-15 minutes to provide additional data on cardiac function under exertion.
Cardiac MRI 2 - With Gadolinium ContrastDiagnostic test
Cines for cardiac function and volumes, T2 myomaps, Resting perfusion and strain analysis, Tagging (strain), T1 myomaps, Late gadolinium enhancement
During the MRI scan participants would be required perform a short period of low intensity exercise involving peddling on an adapted cycle for 10-15 minutes to provide additional data on cardiac function under exertion.
Cardiac MRI 3 - Without Gadolinium ContrastDiagnostic test
Cines for cardiac function and volumes, T2 myomaps, Resting perfusion and strain analysis, Tagging (strain), T1 myomaps.
During the MRI scan participants would be required perform a short period of low intensity exercise involving peddling on an adapted cycle for 10-15 minutes to provide additional data on cardiac function under exertion.
Cardiac MRI 3 - With Gadolinium ContrastDiagnostic test
Cines for cardiac function and volumes, T2 myomaps, Resting perfusion and strain analysis, Tagging (strain), T1 myomaps, Late gadolinium enhancement
During the MRI scan participants would be required perform a short period of low intensity exercise involving peddling on an adapted cycle for 10-15 minutes to provide additional data on cardiac function under exertion.
Peripheral Whole Blood SamplesDiagnostic test
20ml EDTA whole blood samples - collected sequentially during study - max 8 time points
| Study group | Role | What they receive |
|---|---|---|
| Pre Dialysis (CKD Stage 4/5) | Patients recruited from low clearance clinic with advanced CKD (stage 4/5). Patients will undergo Cardiac MRI 1 - With Gadolinium Contrast at the time of recruitment and Cardiac MRI 2 - With Gadolinium Contrast at time of commencement on renal replacement therapy. Patients will have Peripheral Whole Blood Samples taken at defined intervals. Receives: Diagnostic Test: Cardiac MRI 1 - With Gadolinium Contrast; Diagnostic Test: Cardiac MRI 2 - With Gadolinium Contrast; Diagnostic Test: Peripheral Whole Blood Samples | |
| Haemodialysis Dialysis (CDK Stage 5d) | Patients started on Haemodialysis will have Cardiac MRI 3 - With Gadolinium Contrast after 6 months of therapy. Patients will have Peripheral Whole Blood Samples taken at defined intervals. Receives: Diagnostic Test: Cardiac MRI 3 - With Gadolinium Contrast; Diagnostic Test: Peripheral Whole Blood Samples | |
| Peritoneal Dialysis (CDK Stage 5d) | Patients started on Peritoneal Dialysis will have Cardiac MRI 3 - Without Gadolinium Contrast after 6 months of therapy. Patients will have Peripheral Whole Blood Samples taken at defined intervals. Receives: Diagnostic Test: Cardiac MRI 3 - Without Gadolinium Contrast; Diagnostic Test: Peripheral Whole Blood Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
The development and modulation of myocardial fibrosis and change in cardiac function with CKD progression and commencement on renal replacement therapy
Cardiac MRI assessment of the evolution of myocardial fibrosis and cardiac function using sequential contrast enhanced CMR imaging (at three time points) during transition to end stage renal failure and commencement on renal replacement therapy
Measured: 18 Months
Secondary outcomes (1)
Change in monocyte subsets and biochemical profile in peripheral blood with CKD progression and commencement on renal replacement therapy
Assessment of change in monocyte subset (phenotype and function), plasma cytokine levels and lipid profile in sequential blood samples collected during transition from advanced CKD to commencement on renal replacement therapy correlated with myocardial fibrosis and cardiovascular risk.
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start1 Feb 2019
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Why it stopped: Suspended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial FibrosisStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Imperial College Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Neill Duncan, MBBS FRCP, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857633
- Sponsor's protocol ID
- 18HH4615
- Other IDs
- 221424
- Acronym
- CM3
- Status last verified
- Sep 2021
- First submitted
- 26 Feb 2019
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Process of Inflammation in the Development of Myocardial Fibrosis in Chronic Kidney Disease and End Stage Renal Failure - A Longitudinal Cohort Study Assessing Myocardial Fibrosis Development Using Cardiac MRI Correlated With Monocyte and Biochemical Profile Analysis During Transition to Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT03857633
- Acronym / sponsor ID
- CM3 / 18HH4615
- Conditions
- Myocardial Fibrosis, End Stage Renal Failure on Dialysis, Chronic Kidney Disease, Stage IV (Severe), Chronic Kidney Disease Stage V, Heart Failure
- Keywords
- Cardiac MRI, Myocardial Fibrosis, End Stage Renal Failure, Monocyte Subsets, Renal Replacement Therapy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Suspended
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Imperial College Healthcare NHS Trust
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 28 Feb 2019 (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.
Firstly, this study aims to understand how cardiac fibrosis mediated by inflammatory microvascular disease evolves during advanced chronic kidney disease and end stage renal failure and importantly how this changes with commencement on renal replacement therapy (haemodialysis and peritoneal dialysis) using sequential cardiac MRI imaging. This method of imaging is non-invasive, provides significantly more data than echocardiography, is reproducible and accurate, has been validated in numerous studies and does not involve exposure to ionising radiation.
Secondly, this study aims to examine the changes in monocyte subsets and biochemical profile in peripheral blood prior to, during and after commencement on renal replacement therapy.
The investigators hypothesis would be that renal failure causes alteration in monocyte subset phenotype resulting in increased circulating inflammatory monocytes (human CD14high CD16high), initiating pro-inflammatory cytokine expression and thereby accelerating inflammatory cardiovascular disease and development of myocardial fibrosis.
Detailed description
There is significant excess of cardiac mortality in patients with end stage renal failure (ESRF) - 15 to 20% relative increased risk of cardiac death compared to the normal population. 20-30% of patients on renal replacement therapy (RRT) die from a cardiac cause (UK Renal Registry Data, 2016). However, only 30% have macrovascular disease at the time of autopsy. There is therefore a significant component of cardiac morbidity and mortality in this population that is mediated by microvascular disease and cardiac fibrosis. This includes abnormal myocardial remodelling, increased ventricular stiffness and ventricular hypertrophy, with development of arrhythmia and cardiac failure as well as increased atherosclerotic disease burden. Renal replacement therapy in itself also induces a pro-inflammatory response in patients increasing cardiac risk and there is poor understanding as to how to mediate this risk.
There is a lack of evidence in how to manage both patients and the RRT process to minimise the risk of patients developing cardiac disease. The mechanisms underlying this enhanced risk are not fully understood nor explained by traditional cardiovascular risk factors. The investigators propose to study the mechanism by which this might be mediated.
The investigators have previously reported alterations in monocyte subset populations in CKD patients that importantly predict CVD events. Furthermore, the investigators have shown that dyslipidaemia influences monocyte/macrophage phenotypes. The investigators propose an important interaction exists between chronic inflammation in the uraemic state, dyslipidaemia and the formation of deleterious monocyte/macrophage phenotypes that accelerates atherosclerosis. Cardiac MRI has been used in recent years to accurately assess the degree of cardiac fibrosis in end stage renal failure.
This clinical study builds on previous clinical and non-clinical studies at Imperial College London by unifying basic science, animal models and imaging studies into the clinical context of end stage renal failure. Increased understanding of the changes in cardiac function related to development of end stage renal failure and commencement on renal replacement therapy will provide significant and novel opportunities to optimise the management of patients in the pre-dialysis setting and prevent cardiovascular complications caused by long term renal replacement therapy.
This clinical observational study will involve the recruitment of 30 participants from general nephrology services at Imperial College Healthcare NHS Trust at CKD stage 4/5 with progressive decline in renal function (anticipated start on renal replacement therapy within 6 months). Participants will be divided into two cohorts of haemodialysis and peritoneal dialysis to enable comparison between the renal replacement modalities. As part of participants recruitment they will undergo comprehensive medical assessment and will remain under the follow-up of the renal team at frequent intervals.
Enrolled participants will undergo cardiac MRI imaging at three time points - First when initially recruited at CKD4/5, second at the point of commencement on renal replacement therapy (~6 months) and third after a further 6 months on renal replacement therapy. MRI results will be analysed at these time points for development of fibrotic and function change.
In partnership with MRI imaging patients will have blood samples collected at the same time intervals for analysis of blood count, biochemical markers, monocyte and lipid phenotypes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre Dialysis (CKD Stage 4/5) | – | Diagnostic Test: Cardiac MRI 1 - With Gadolinium Contrast, Diagnostic Test: Cardiac MRI 2 - With Gadolinium Contrast, Diagnostic Test: Peripheral Whole Blood SamplesPatients recruited from low clearance clinic with advanced CKD (stage 4/5). Patients will undergo Cardiac MRI 1 - With Gadolinium Contrast at the time of recruitment and Cardiac MRI 2 - With Gadolinium Contrast at time of commencement on renal replacement therapy. Patients will have Peripheral Whole Blood Samples taken at defined intervals. |
| Haemodialysis Dialysis (CDK Stage 5d) | – | Diagnostic Test: Cardiac MRI 3 - With Gadolinium Contrast, Diagnostic Test: Peripheral Whole Blood SamplesPatients started on Haemodialysis will have Cardiac MRI 3 - With Gadolinium Contrast after 6 months of therapy. Patients will have Peripheral Whole Blood Samples taken at defined intervals. |
| Peritoneal Dialysis (CDK Stage 5d) | – | Diagnostic Test: Cardiac MRI 3 - Without Gadolinium Contrast, Diagnostic Test: Peripheral Whole Blood SamplesPatients started on Peritoneal Dialysis will have Cardiac MRI 3 - Without Gadolinium Contrast after 6 months of therapy. Patients will have Peripheral Whole Blood Samples taken at defined intervals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced and progressive Chronic Kidney Disease (Stage 4/5) - under low clearance follow-up who are expected to start renal replacement therapy (either haemodialysis or peritoneal dialysis) within 6 months.
Key inclusion criteria (4 listed)
- Patients with a diagnosis of Chronic Kidney Disease stage 4 and above
- Patients with a progressive decline in renal function with a expectation to require future renal replacement therapy or currently on renal replacement therapy (Haemodialysis or Peritoneal Dialysis)
- Exclusion of macrovascular cardiac disease within the last 3 years
- Access for haemodialysis planned via tunnelled central venous catheter
Key exclusion criteria (12 listed)
- Age under eighteen
- Patients with a diagnosis of Diabetes Mellitus
- Untreated macrovascular cardiac disease or Acute Coronary syndrome within 6 months of recruitment
- Previous or current treatment with immunosuppressive/modulatory therapy
- Current Malignancy
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 MRI 1 - With Gadolinium ContrastCines for cardiac function and volumes, T2 myomaps, Resting perfusion and strain analysis, Tagging (strain), T1 myomaps, Late gadolinium enhancement During the MRI scan participants would be required perform a short period of low intensity exercise involving peddling on an adapted cycle for 10-15 minutes to provide additional data on cardiac function under exertion. | Diagnostic test | Pre Dialysis (CKD Stage 4/5) |
| Cardiac MRI 2 - With Gadolinium ContrastCines for cardiac function and volumes, T2 myomaps, Resting perfusion and strain analysis, Tagging (strain), T1 myomaps, Late gadolinium enhancement During the MRI scan participants would be required perform a short period of low intensity exercise involving peddling on an adapted cycle for 10-15 minutes to provide additional data on cardiac function under exertion. | Diagnostic test | Pre Dialysis (CKD Stage 4/5) |
| Cardiac MRI 3 - Without Gadolinium ContrastCines for cardiac function and volumes, T2 myomaps, Resting perfusion and strain analysis, Tagging (strain), T1 myomaps. During the MRI scan participants would be required perform a short period of low intensity exercise involving peddling on an adapted cycle for 10-15 minutes to provide additional data on cardiac function under exertion. | Diagnostic test | Peritoneal Dialysis (CDK Stage 5d) |
| Cardiac MRI 3 - With Gadolinium ContrastCines for cardiac function and volumes, T2 myomaps, Resting perfusion and strain analysis, Tagging (strain), T1 myomaps, Late gadolinium enhancement During the MRI scan participants would be required perform a short period of low intensity exercise involving peddling on an adapted cycle for 10-15 minutes to provide additional data on cardiac function under exertion. | Diagnostic test | Haemodialysis Dialysis (CDK Stage 5d) |
| Peripheral Whole Blood Samples20ml EDTA whole blood samples - collected sequentially during study - max 8 time points | Diagnostic test | Haemodialysis Dialysis (CDK Stage 5d), Peritoneal Dialysis (CDK Stage 5d), Pre Dialysis (CKD Stage 4/5) |
Primary outcome
The development and modulation of myocardial fibrosis and change in cardiac function with CKD progression and commencement on renal replacement therapy
Time frame: 18 Months
Cardiac MRI assessment of the evolution of myocardial fibrosis and cardiac function using sequential contrast enhanced CMR imaging (at three time points) during transition to end stage renal failure and commencement on renal replacement therapy
1 secondary outcome
Change in monocyte subsets and biochemical profile in peripheral blood with CKD progression and commencement on renal replacement therapy
Time frame: 18 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Neill Duncan, MBBS FRCP principal investigator
Imperial College Healthcare NHS 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 Myocardial Fibrosis and End Stage Renal Failure on Dialysis, run by Imperial College London 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 4 inclusion and 12 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: withdrawn, as of the sponsor's last update on 8 Oct 2021. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The development and modulation of myocardial fibrosis and change in cardiac function with CKD progression and commencement on renal replacement therapy (time frame: 18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2021.