RecruitingNot Applicable

Cardiac Tissue Sodium Assessment in CKD Patients Using Sodium MRI

Canada150 participantsStarted 2022-07-10

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study is measuring sodium signals in heart tissue using a special MRI — how is this different from the regular MRIs or cardiac tests I might already be getting for my CKD, and would I need to stop or change any of my current care to participate?
2Since this trial is listed as 'Phase NA,' it seems to be more of an observational or imaging study rather than one testing a new treatment — does that mean there's no experimental drug or intervention involved, and what would I actually gain from taking part beyond contributing to research?
3The study is looking at sodium retention in the heart in people with CKD and those on dialysis — given my specific stage of kidney disease, would my doctor consider me a good candidate to discuss with the research team, and what would the screening process look like?
4Sodium buildup in the heart is a serious concern in CKD — if the MRI scan from this study detected something unusual in my cardiac sodium levels, would that information be shared with my care team and could it change my treatment plan?
5Are there any risks associated with this type of sodium MRI scan that are different from a standard MRI, and are there any reasons related to my kidney disease or dialysis schedule that could make the scan unsafe or difficult for me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Difference in Cardiac Sodium Signal

Timeframe: Baseline

Trial details

NCT IDNCT04848636

SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-07-31

Contact for this trial

Christopher W McIntyre, MD/PhD

5196858500 christopher.mcintyre@lhsc.on.ca

View on ClinicalTrials.gov More Chronic Kidney Diseases trials