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A multicenter, open-label, single-arm clinical study of recombinant human brain natriuretic peptide in the treatment of patients with end-stage heart failure

A multicenter, open-label, single-arm clinical study of recombinant human brain natriuretic peptide in the treatment of patients with end-stage heart failure

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128287
Enrollment
Unknown
Registered
2026-07-17
Start date
2025-11-07
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

end-stage heart failure

Interventions

Test group:Recombinant human brain natriuretic peptide, dosage 0.01 ug/kg/min, continuous micro-pump application for 3 days

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 18 - 85 years old, gender not restricted; 2. Patients diagnosed with end-stage heart failure ; 3. Have received the most optimized evidence-based drug treatment for at least 4 weeks (unless there are contraindications or intolerance); 4. Have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Cardiogenic shock or hemodynamic instability; 2. Systolic blood pressure < 90 mmHg; 3. Acute myocardial infarction or unstable angina pectoris within 4 weeks; 4. Planned to undergo heart transplantation or mechanical circulatory support during the trial; 5. Severe valvular disease requiring surgical treatment; 6. Estimated glomerular filtration rate < 15 mL/min/1.73m² or renal replacement therapy; 7. Severe liver dysfunction (Child-Pugh C grade); 8. Malignant tumor or life expectancy < 12 months; 9. Pregnant or lactating women; 10. Allergic to rhBNP or any of its components; 11. Patients with low cardiac filling pressure; 12. Participated in other clinical trials within the past 30 days;

Design outcomes

Primary

MeasureTime frame
New York Heart Association,NYHA;

Secondary

MeasureTime frame
Quality of life;NT-proBNP;6-minute walk distance;Noninvasive Hemodynamic Monitoring;Renal function;

Countries

China

Contacts

Public ContactDachun Xu

Shanghai Tenth People's Hospital

Xdc77@tongji.edu.cn+86 21 66301090

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026