Chronic Kidney DiseasesNCT04848636
Cardiac Tissue Sodium Assessment in CKD Patients Using Sodium MRI
An observational study of Chronic Kidney Diseases and Dialysis; Complications, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Chronic kidney disease (CKD) is prevalent worldwide and affects around 10% of people living in developed health economies. As the kidney loses its function in patients with CKD, the kidneys are unable to filter toxins out of the blood as efficiently as those of healthy individuals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Dialysis; Complications, Sodium Retention
- What is being tested?
- Cardiac Sodium and Proton MRI
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jul 2022to 31 Dec 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient participants with chronic kidney disease or currently receiving hemodialysis treatment from London Health Sciences Centre Regional Renal Program, London, Ontario Age and sex matched healthy participants
Who may be able to join
- Age greater than or equal to 18 years
- For patients on maintenance hemodialysis: more than 3 months duration of therapy
- For patients with CKD: evidence of kidney disease persisting > 3 months and no indications to start dialysis
- For healthy controls: lack of kidney disease, cardiovascular disease, diabetes, liver cirrhosis and peripheral edema
Who cannot join
- Pregnant, breastfeeding or intending pregnancy
- Contraindication to MRI scan
- Inability to tolerate MRI due to patient size and/or known history of claustrophobia.
- Mechanically implanted, electrically, or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, tattoos, shunt, surgical staples (including clips or metallic sutures and/or ear implants.)
Trial locations and contacts
1 site in 1 country.
Taylor L Marcus, BMSc contact
Canada1 site, 1 recruiting
- Recruiting
Victoria Hospital
London, Ontario, N6A5W9
Christopher W McIntyre, MD/PhD, 5196858500 ext. 58502, christopher.mcintyre@lhsc.on.ca
About this study
Official title: Sodium Assessment of the Cardiac Tissue in Chronic Kidney Disease Patients Using Sodium Magnetic Resonance Imaging
Chronic kidney disease (CKD) is prevalent worldwide and affects around 10% of people living in developed health economies. As the kidney loses its function in patients with CKD, the kidneys are unable to filter toxins out of the blood as efficiently as those of healthy individuals. Arguably, sodium (salt) is the most relevant toxin in CKD and can build up in the kidneys of patients with CKD. Salt build-up has also been found to occur in the heart muscle tissue and could drive the development of scarring of the heart muscle tissue which contributes to heart failure.
Using sodium magnetic resonance imaging (MRI), we would like to measure the levels of salt in the heart muscle tissue. We will examine whether the heart muscle tissue has high salt levels, and if so, whether this relates to any heart defects. A conventional proton MRI will be done to measure heart function. The MRI images of healthy volunteers, CKD patients, and those on hemodialysis will be analyzed for levels of salt and the findings will then be compared to the cardiac biomarkers (proteins or enzymes that are released into the blood when the heart is damaged or stressed) and fibrosis (scarring) measured from each patient's proton MRI images to establish a possible correlation. This research has the potential to precede additional studies that may investigate the effect of diuretics (a drug that increases the production of urine) on the heart muscle tissue of CKD patients.
Using sodium magnetic resonance imaging (MRI), it is possible to measure the sodium content in the cardiac tissue of patients with kidney disease. In this research study, it will be investigated whether the elevated levels of sodium in patients with kidney disease is also present in their hearts, and if so, whether this relates to cardiac abnormalities. Cardiac sodium MRI images of healthy volunteers, hemodialysis patients, and CKD patients will be analyzed for sodium content. This sodium information will then be compared to the biomarkers of cardiac function and fibrosis measured from each patient's proton MRI images in order to establish a possible correlation. This research has the potential to precede additional studies that may investigate the effect of diuretics on the cardiac tissue of kidney disease patients.
Read the detailed description
This study is a pilot exploratory study (preliminary project to assess the use of a heart sodium coil across a wide spectrum of kidney disease). We will recruit up to 150 participants: approximately 50 hemodialysis patients, 50 patients with various stages of chronic kidney disease, and 50 age and sex matched healthy participants to compare clinical characteristics to. This study involves one study visit at the Robarts Research Institute, London, Ontario lasting approximately 3 hours.
This study entails one visit where all participants will undergo a proton and sodium MRI scan of the heart. Prior to the scan, all participants will have their sitting blood pressure and heart rate measured three times consecutively using a standard automatic blood pressure monitor. In addition to this, all patient participants will have blood work collected, provide a spot urine sample, complete a salt intake questionnaire, and have their fluid volume measured using bioimpedance spectroscopy. Only those patients on hemodialysis will answer a single Time to Recovery Question in addition to the above.
- Being tested
- Cardiac Sodium and Proton MRI
- Keywords
- Sodium MRI, Chronic Kidney Disease, Hemodialysis
- Medical subject headings
- Renal Insufficiency, Chronic, Hypernatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Sodium and Proton MRIDiagnostic test
Sodium-23 MRI of the Heart Proton MRI of the Heart
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | * Age greater than or equal to 18 years
* lack of kidney disease, cardiovascular disease, diabetes, liver cirrhosis and peripheral edema Receives: Diagnostic Test: Cardiac Sodium and Proton MRI | |
| Chronic Kidney Disease Patients | * Age greater than or equal to 18 years
* evidence of kidney disease persisting > 3 months and no indications to start dialysis Receives: Diagnostic Test: Cardiac Sodium and Proton MRI | |
| Hemodialysis Patients | * Age greater than or equal to 18 years
* more than 3 months duration of therapy Receives: Diagnostic Test: Cardiac Sodium and Proton MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Cardiac Sodium Signal
Difference in Cardiac Sodium Signal between hemodialysis patients, chronic kidney disease patients, and sex and age-matched healthy adult controls.
Measured: Baseline
Secondary outcomes (7)
Dialysate Composition
Correlation between Cardiac Sodium Signal and dialysate composition.
Measured: Baseline
Serum Sodium Concentration
Correlation between Cardiac Sodium Signal and serum sodium concentration. Serum sodium concentration will be measured from a blood sample in mmol/L.
Measured: Baseline
Proton MRI Biomarkers
Correlation between Cardiac Sodium Signal and left ventricular mass, end diastolic volume, and left atrial volume.
Measured: Baseline
T1 Mapping
Correlation between Cardiac Sodium Signal and T1 times in the left ventricular wall.
Measured: Baseline
T2 Mapping
Correlation between Cardiac Sodium Signal and T2 times in the left ventricular wall.
Measured: Baseline
Serum Albumin
Correlation between Cardiac Sodium Signal and serum albumin. Serum albumin will be measured from a blood sample in g/L.
Measured: Baseline
Serum High-Sensitivity Troponin T
Correlation between Cardiac Sodium Signal and serum high-sensitivity troponin T. Serum high-sensitivity troponin T will be measured from a blood sample in ng/L.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start10 Jul 2022
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chris McIntyre, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Christopher W McIntyre, MD/PhD, Principal investigator, London Health Sciences Centre - Victoria Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848636
- Sponsor's protocol ID
- 118891
- Status last verified
- Jul 2024
- First submitted
- 31 Mar 2021
- Last updated
- 24 Jul 2024
- 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 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Assessment of the Cardiac Tissue in Chronic Kidney Disease Patients Using Sodium Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT04848636
- Acronym / sponsor ID
- 118891
- Keywords
- Sodium MRI, Chronic Kidney Disease, Hemodialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 10 Jul 2022 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Apr 2021 (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.
Chronic kidney disease (CKD) is prevalent worldwide and affects around 10% of people living in developed health economies. As the kidney loses its function in patients with CKD, the kidneys are unable to filter toxins out of the blood as efficiently as those of healthy individuals. Arguably, sodium (salt) is the most relevant toxin in CKD and can build up in the kidneys of patients with CKD. Salt build-up has also been found to occur in the heart muscle tissue and could drive the development of scarring of the heart muscle tissue which contributes to heart failure.
Using sodium magnetic resonance imaging (MRI), we would like to measure the levels of salt in the heart muscle tissue. We will examine whether the heart muscle tissue has high salt levels, and if so, whether this relates to any heart defects. A conventional proton MRI will be done to measure heart function. The MRI images of healthy volunteers, CKD patients, and those on hemodialysis will be analyzed for levels of salt and the findings will then be compared to the cardiac biomarkers (proteins or enzymes that are released into the blood when the heart is damaged or stressed) and fibrosis (scarring) measured from each patient's proton MRI images to establish a possible correlation. This research has the potential to precede additional studies that may investigate the effect of diuretics (a drug that increases the production of urine) on the heart muscle tissue of CKD patients.
Using sodium magnetic resonance imaging (MRI), it is possible to measure the sodium content in the cardiac tissue of patients with kidney disease. In this research study, it will be investigated whether the elevated levels of sodium in patients with kidney disease is also present in their hearts, and if so, whether this relates to cardiac abnormalities. Cardiac sodium MRI images of healthy volunteers, hemodialysis patients, and CKD patients will be analyzed for sodium content. This sodium information will then be compared to the biomarkers of cardiac function and fibrosis measured from each patient's proton MRI images in order to establish a possible correlation. This research has the potential to precede additional studies that may investigate the effect of diuretics on the cardiac tissue of kidney disease patients.
Detailed description
This study is a pilot exploratory study (preliminary project to assess the use of a heart sodium coil across a wide spectrum of kidney disease). We will recruit up to 150 participants: approximately 50 hemodialysis patients, 50 patients with various stages of chronic kidney disease, and 50 age and sex matched healthy participants to compare clinical characteristics to. This study involves one study visit at the Robarts Research Institute, London, Ontario lasting approximately 3 hours.
This study entails one visit where all participants will undergo a proton and sodium MRI scan of the heart. Prior to the scan, all participants will have their sitting blood pressure and heart rate measured three times consecutively using a standard automatic blood pressure monitor. In addition to this, all patient participants will have blood work collected, provide a spot urine sample, complete a salt intake questionnaire, and have their fluid volume measured using bioimpedance spectroscopy. Only those patients on hemodialysis will answer a single Time to Recovery Question in addition to the above.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Diagnostic Test: Cardiac Sodium and Proton MRI* Age greater than or equal to 18 years * lack of kidney disease, cardiovascular disease, diabetes, liver cirrhosis and peripheral edema |
| Chronic Kidney Disease Patients | – | Diagnostic Test: Cardiac Sodium and Proton MRI* Age greater than or equal to 18 years * evidence of kidney disease persisting > 3 months and no indications to start dialysis |
| Hemodialysis Patients | – | Diagnostic Test: Cardiac Sodium and Proton MRI* Age greater than or equal to 18 years * more than 3 months duration of therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient participants with chronic kidney disease or currently receiving hemodialysis treatment from London Health Sciences Centre Regional Renal Program, London, Ontario Age and sex matched healthy participants
Key inclusion criteria (4 listed)
- Age greater than or equal to 18 years
- For patients on maintenance hemodialysis: more than 3 months duration of therapy
- For patients with CKD: evidence of kidney disease persisting > 3 months and no indications to start dialysis
- For healthy controls: lack of kidney disease, cardiovascular disease, diabetes, liver cirrhosis and peripheral edema
Key exclusion criteria (4 listed)
- Pregnant, breastfeeding or intending pregnancy
- Contraindication to MRI scan
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 Sodium and Proton MRISodium-23 MRI of the Heart Proton MRI of the Heart | Diagnostic test | Chronic Kidney Disease Patients, Healthy Controls, Hemodialysis Patients |
Primary outcome
Difference in Cardiac Sodium Signal
Time frame: Baseline
Difference in Cardiac Sodium Signal between hemodialysis patients, chronic kidney disease patients, and sex and age-matched healthy adult controls.
7 secondary outcomes
Dialysate Composition
Time frame: Baseline
Serum Sodium Concentration
Time frame: Baseline
Proton MRI Biomarkers
Time frame: Baseline
T1 Mapping
Time frame: Baseline
T2 Mapping
Time frame: Baseline
Serum Albumin
Time frame: Baseline
Serum High-Sensitivity Troponin T
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- 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.
Taylor L Marcus, BMSc contact
Christopher W McIntyre, MD/PhD principal investigator
London Health Sciences Centre - Victoria Hospital
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 Dialysis; Complications, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 4 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 24 Jul 2024. 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 Canada. 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 Christopher W McIntyre, MD/PhD (5196858500 ext. 58502, christopher.mcintyre@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Cardiac Sodium Signal (time frame: Baseline). 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 24 Jul 2024.