Measuring sodium levels in heart tissue of patients with chronic kidney disease using MRI
Sodium Assessment of the Cardiac Tissue in Chronic Kidney Disease Patients Using Sodium Magnetic Resonance Imaging
This study is testing if measuring sodium levels in the heart tissue of people with chronic kidney disease can help us understand if high sodium is linked to heart problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT04848636 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess sodium levels in the heart muscle tissue of patients with chronic kidney disease (CKD) using sodium magnetic resonance imaging (MRI). It will involve up to 150 participants, including hemodialysis patients, CKD patients, and healthy controls, who will undergo both sodium and proton MRI scans. The study will also collect various health metrics, including blood pressure, heart rate, blood samples, and fluid volume measurements. The goal is to determine if high sodium levels in heart tissue correlate with heart defects in CKD patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with chronic kidney disease or those on maintenance hemodialysis for more than three months.
Not a fit: Patients who are pregnant, breastfeeding, or have contraindications to MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of heart complications in patients with chronic kidney disease.
How similar studies have performed: While sodium MRI is a novel approach in this context, similar imaging techniques have shown promise in other studies assessing cardiac health.
Eligibility criteria
Show full inclusion / exclusion criteria
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.)
Where this trial is running
London, Ontario
- Victoria Hospital — London, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Christopher W McIntyre, MD/PhD — London Health Sciences Centre - Victoria Hospital
- Study coordinator: Christopher W McIntyre, MD/PhD
- Email: christopher.mcintyre@lhsc.on.ca
- Phone: 5196858500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.