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Investigation of Different rhBNP Treatment Courses in Acute Decompensated Heart Failure

Assessment of Treatment Duration Effects with Recombinant Human Brain Natriuretic Peptide in ADHF Patients: A Focus on Efficacy and Safety Profiles

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109663
Enrollment
Unknown
Registered
2025-09-23
Start date
2025-09-26
Completion date
Unknown
Last updated
2025-09-29

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

Conditions

Acute Decompensated Heart Failure (ADHF)

Interventions

Treatment with Nesiritide for 5 days Group:NA
Treatment with Nesiritide for 3 days Group:NA

Sponsors

The Second Affiliated hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years, regardless of gender. 2. Clearly diagnosed with acute decompensated heart failure, with time of diagnosis not exceeding 48 hours; patients presenting to the emergency department or hospitalized with acute heart failure, exhibiting signs and symptoms of acute heart failure including but not limited to exertional dyspnea, paroxysmal nocturnal dyspnea, orthopnea, fatigue, and fluid retention (e.g., pulmonary edema or peripheral edema). 3. Patients must undergo plasma NT-proBNP testing, with NT-proBNP levels >450 ng/L for those under 50 years old, >900 ng/L for those aged 50–75, >1800 ng/L for those over 75 years old, and >1200 ng/L in cases of renal insufficiency (eGFR <60 ml·min?¹·1.73 m?²). 4. NYHA functional class III–IV (according to the New York Heart Association classification: Class III—marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes significant shortness of breath, fatigue, or palpitations; Class IV—symptoms present even at rest, with any physical activity causing discomfort. Class IVa: able to perform minimal activities at home or bedside without intravenous drug therapy; Class IVb: unable to leave bed and requiring intravenous drug support). 5. Willing to participate in the trial and provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Anticipated length of hospital stay 2.5 times the upper limit of normal (ULN); 5. Women who are pregnant, breastfeeding, or planning to become pregnant; 6. Known or suspected hypersensitivity to the investigational product or any of its components; 7. Participation in another clinical trial within the past month; 8. Any other condition that, in the opinion of the investigator, may pose a risk to the patient; 9. Patients with known allergy to any drug involved in this study.

Design outcomes

Primary

MeasureTime frame
Remission Rate (On the 5th day after rhBNP treatment, the percentage of cases where the clinical comprehensive efficacy assessment is "marked effect" or "effective" among the total number of cases);

Secondary

MeasureTime frame
The severity of dyspnea;NT-proBNP;Left Ventricular Ejection Fraction (LVEF);

Countries

China

Contacts

Public ContactZhenhua Wang

The Second Affiliated hospital of Fujian Medical University

fyeykj19@163.com+86 595 2279 3591

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026