Cardiac Tissue Sodium Assessment in CKD Patients Using Sodium MRI

NCT04848636 | Recruiting

• 1 other identifier: 118891
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Diseases; Dialysis; Complications; Sodium Retention

Keywords

Sodium MRI; Chronic Kidney Disease; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (7)

• Dialysate Composition

  Baseline

• Serum Sodium Concentration

  Baseline

• Proton MRI Biomarkers

  Baseline

• T1 Mapping

  Baseline

• T2 Mapping

  Baseline

Study Arms (3)

Healthy Controls

* Age greater than or equal to 18 years * lack of kidney disease, cardiovascular disease, diabetes, liver cirrhosis and peripheral edema

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

Diagnostic Test: Cardiac Sodium and Proton MRI

Hemodialysis Patients

* Age greater than or equal to 18 years * more than 3 months duration of therapy

Diagnostic Test: Cardiac Sodium and Proton MRI

Interventions

Cardiac Sodium and Proton MRI DIAGNOSTIC_TEST

Sodium-23 MRI of the Heart Proton MRI of the Heart

Chronic Kidney Disease Patients; Healthy Controls; Hemodialysis Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Victoria Hospital

London, Ontario, N6A5W9, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Complete blood count, kidney function (serum creatinine, cystatin C for healthy controls and CKD patients, urea, and electrolytes), liver function, serum albumin, cardiac biomarkers (high-sensitivity cardiac Troponin T), C-reactive protein, serum glucose. A spot urine sample will be collected on the day of the study and will be analyzed for sodium, creatinine, protein, and albumin levels.

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypernatremia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Christopher W McIntyre, MD/PhD

  London Health Sciences Centre - Victoria Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher W McIntyre, MD/PhD

CONTACT

5196858500; christopher.mcintyre@lhsc.on.ca

Taylor L Marcus, BMSc

CONTACT

tmarcus@uwo.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Kidney Clinical Research Unit

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 19, 2021
• Study Start: July 10, 2022
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)