Uremia with hemodialysis complicated by heart failure
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old 2. All patients meet the clinical diagnosis and staging criteria for chronic renal failure. 3. Stable hemodialysis (HD) for more than 3 months (all patients receive 3 HD sessions or hemodiafiltration per week) 4. Hemoglobin (Hb) >=110g/L 5. NT-proBNP >=5000pg/mL 6. SpKt/V >=1.2. After 1 month of conventional intensive treatment for hemodialysis patients, add rhBNP (administered intravenously at 1.5-2ug/kg per bolus, followed by continuous infusion at 0.015µg/kg/min for 4 hours, 3 times per week, for 4 consecutive weeks) Screening of patients Primary outcome: Change in left ventricular mass index before and after rhBNP treatment Secondary outcomes: Changes in pulmonary artery systolic pressure, NT-proBNP, quality of life scores, and incidence of adverse reactions before and after rhBNP treatment Clinical Research Center, First Affiliated Hospital of Zhengzhou University IIT-ZD-002-ATT02 Interventional Clinical Research Protocol Template Page 9 of 17 7. Cardiac function classification of grade III or IV (according to NYHA classification) (diagnosis of heart failure follows the "Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2024") 8. Agree to participate in the trial and sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women. 2. Individuals known to be allergic to the components of the study drug. 3. Severe stenosis of mitral and aortic valves. 4. Restrictive or obstructive cardiomyopathy. 5. Restrictive pericarditis. 6. Cardiac tamponade. 7. Acute coronary syndrome. 8. Left-to-right shunt in the heart. 9. Acute pulmonary embolism. 10. Chest wall or parenchymal lung disease. 11. Individuals who have used immunosuppressants for various reasons within the past 6 months. 12. Insufficient dialysis. 13. Acute renal failure. 14. Patients with systolic blood pressure <90 mmHg. 15. Patients with expected survival <6 months. 16. Cardiogenic shock. 17. Patients with low cardiac filling pressure. 18. OH greater than 8% of dry weight (BCM detection). 19. Individuals deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in left ventricular mass index before and after rhBNP treatment in patients; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary artery systolic pressure;Adverse reaction rate;Nt-proBNP;6-minute walk test;SF-36v2 scale score; | — |
Countries
China
Contacts
The First Affiliated Hospital of Zhengzhou University