Effect of potassium-lowering drugs on heart stability in dialysis patients

The Effect of Potassium Lowering Drugs on Cardiac Electrical Stability in Hemodialysis

This study tests if a new drug can help keep the hearts of dialysis patients stable by lowering their potassium levels.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 61 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University First Hospital (other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06242041 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective, randomized controlled study investigates the impact of sodium zirconium silicate on cardiac electrical stability in patients undergoing hemodialysis. The study includes a one-week screening period followed by a seven-week treatment phase, where patients are randomly assigned to either a control group or a treatment group receiving the drug. Blood potassium levels are monitored before and after dialysis, and the relationship between potassium levels and ECG stability is evaluated. The goal is to maintain potassium levels within a target range to improve cardiac health.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with end-stage kidney disease receiving hemodialysis and consistently elevated potassium levels.

Not a fit: Patients with poor compliance to dialysis treatment or those with recent acute cardiovascular events may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved cardiac stability and reduced risk of arrhythmias in hemodialysis patients with potassium imbalance.

How similar studies have performed: Other studies have explored potassium management in dialysis patients, but the specific use of sodium zirconium silicate in this context is relatively novel.

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.

Where this trial is running

Beijing, Beijing

• Peking University first hospital hemodialysis center — Beijing, Beijing, China (RECRUITING)

Study contacts

• Study coordinator: LI LIU

Conditions: Potassium Imbalance, Cardiac Arrhythmia, Dialysis, Complications, Hyperkalemia, Chronic kidney disease, Maintenance hemodialysis, cardiac electrical stability