The Effect of Potassium Lowering Drugs on Cardiac Electrical Stability in Hemodialysis Patients (ART Study)

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Jan 28, 2024

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ClinConnect Summary

The ART Study is a clinical trial looking at how a medication called sodium zirconium silicate can help patients on dialysis manage high potassium levels and improve heart stability. High potassium can lead to serious heart problems, so the study aims to see if this drug can keep potassium levels in a safe range and, in turn, help the heart function better. This study is open to adults aged 18 and older who have been receiving hemodialysis (a type of kidney treatment) at least three times a week for more than three months and have had consistently high potassium levels before dialysis.

Participants in the trial will go through a week of screening to determine eligibility, followed by seven weeks of treatment. During the treatment phase, those in the group receiving the drug will take it on days they do not have dialysis, while their potassium levels will be monitored closely. Additionally, heart health will be checked through ECG tests at the start and end of the treatment. This study is important for understanding how to better manage potassium levels in dialysis patients and improve their overall heart health.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age≥18 years old.
• • 2. ESKD received hemodialysis treatment three times a week for more than 3 months.
• • 3. After a long interval, before dialysis, the serum potassium was≥5.0mmol/L and was examined for two months in a row.
• • 4. Screening patients with serum potassium≥5.0mmol/L before dialysis.
• Exclusion Criteria:
• • 1. poor compliance with dialysis treatment.
• • 2. Acute myocardial infarction, acute coronary syndrome, stroke, epilepsy or thromboembolism (such as deep vein thrombosis or pulmonary embolism, but excluding hemodialysis pathway thrombosis) occurred within 12 weeks before the screening date.
• • 3. Hypokalemia (blood potassium\<3.5mmol/L), hypocalcemia (blood calcium\<2.1mmol/L), hypocalcemia (blood magnesium\<0.7mmol/L) or severe acidosis (blood bicarbonate\<16mmol/L) occurred within 4 weeks before the screening date.
• • 4. Severe hematological abnormalities: white blood cells\>20×10\^9/L, platelets≥450×10\^9/L.
• • 5. Rhabdomyolysis was diagnosed 4 weeks before screening.
• • 6. Taking lactulose, rifaximin or other unabsorbed antibiotics to treat hyperammonemia within 7 days before taking the first medicine.
• • 7. Patients cannot take sodium zirconium silicate orally.
• • 8. The patient is allergic to sodium zirconium silicate or other components of the drug.
• • 9. The life expectancy of patients is less than 1 year.
• • 10. Patients during pregnancy and lactation.
• • 11. Female patients preparing for pregnancy during the study period.
• • 12. Participated in clinical research of other drugs in the month before screening.
• • 13. Persons who have lost their autonomous capacity.