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NCT Number: NCT04848636

Cardiac Tissue Sodium Assessment in CKD Patients Using Sodium MRI

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Victoria Hospital

London, Ontario, N6A5W9, Canada

Location status: Recruiting

Location contact

Christopher W McIntyre, MD/PhD

CONTACT

[email protected]

5196858500 ext. 58502

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Cardiac Sodium and Proton MRI

Diagnostic Test

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Dialysate Composition

    Time frame: Baseline

    Correlation between Cardiac Sodium Signal and dialysate composition.

  2. Serum Sodium Concentration

    Time frame: Baseline

    Correlation between Cardiac Sodium Signal and serum sodium concentration. Serum sodium concentration will be measured from a blood sample in mmol/L.

  3. Proton MRI Biomarkers

    Time frame: Baseline

    Correlation between Cardiac Sodium Signal and left ventricular mass, end diastolic volume, and left atrial volume.

  4. T1 Mapping

    Time frame: Baseline

    Correlation between Cardiac Sodium Signal and T1 times in the left ventricular wall.

  5. T2 Mapping

    Time frame: Baseline

    Correlation between Cardiac Sodium Signal and T2 times in the left ventricular wall.

  6. Serum Albumin

    Time frame: Baseline

    Correlation between Cardiac Sodium Signal and serum albumin. Serum albumin will be measured from a blood sample in g/L.

  7. Serum High-Sensitivity Troponin T

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher W McIntyre, MD/PhD

CONTACT

[email protected]

5196858500 ext. 58502

Taylor L Marcus, BMSc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Sodium Assessment of the Cardiac Tissue in Chronic Kidney Disease Patients Using Sodium Magnetic Resonance Imaging

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 19, 2021
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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