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The efficacy and safety of recombinant human brain natriuretic peptide in patients with acute heart failure (AHF) complicated with chronic renal insufficiency: A prospective, single-center, single-arm trial

The efficacy and safety of recombinant human brain natriuretic peptide in patients with acute heart failure (AHF) complicated with chronic renal insufficiency: A prospective, single-center, single-arm trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107963
Enrollment
Unknown
Registered
2025-08-21
Start date
2025-08-22
Completion date
Unknown
Last updated
2025-08-25

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

Conditions

AHF complicated with chronic renal insufficiency

Interventions

Single-arm clinical study enrolling patients with AHF combined with chronic renal insufficiency.:The included patients were given conventional heart failure treatment and rhBNP was given on top of thi

Sponsors

Tongji Hospital of Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.18 to 80 years old; 2.Meet the diagnostic criteria in the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2024: symptoms and signs of acute heart failure, including but not limited to exertional dyspnea, nocturnal paroxysmal dyspnea, sedentary respiration, malaise, and fluid retention (e.g., pulmonary edema or peripheral edema); and stratified according to age and renal function, patients are diagnosed as having acute heart failure when their NTproBNP reaches the following levels Heart failure: patients need to undergo plasma NTproBNP level testing, NTproBNP>450ng/L in patients under 50 years old, >900ng/L in 50-75 years old, >1800ng/L in 75 years old or above, and >1200ng/L in case of renal insufficiency (eGFR<60ml*min-1*1.73m-2). 3.Meet the G3 and G4 stages in the chronic kidney disease (CKD) staging in the Guidelines for Early Screening, Diagnosis and Prevention of Chronic Kidney Disease (2022 Edition). (15ml/min < glomerular filtration rate < 60ml/min). 4.Patients participated voluntarily and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients who are allergic to any of the components in recombinant human brain natriuretic peptide and patients with cardiogenic shock or systolic blood pressure <90 mmHg. 2.Patients who are not candidates for vasodilator drugs such as those with severe valvular stenosis, restrictive or obstructive cardiomyopathy, restrictive pericarditis, pericardial tamponade, or other patients whose cardiac output is dependent on venous return or who are suspected of having a low cardiac filling pressure. 3.Combination of malignant tumors. 4.Patients with HF secondary to end-stage disease of the liver, brain, or other vital organs. 5.Life expectancy of less than 12 months in combination with other serious diseases. 6.Pregnant or lactating women. 7.Patients with severe renal insufficiency requiring dialysis. 8.Major organ dysfunction and failure. 9.Presence of alcohol and drug abuse history. 10.Patients with combined autoimmune diseases. 11.Concomitant diseases requiring surgical intervention. 12.Patients who have difficulties in participating in the survey or accepting follow-up, such as non-cooperation and limited legal capacity.

Design outcomes

Primary

MeasureTime frame
Rate of readmission due to cardiogenic factors or heart failure within 1 month of discharge.;

Secondary

MeasureTime frame
Complete blood cell (CBC)-derived indicators of inflammation;

Countries

China

Contacts

Public ContactChen Lin

Tongji Hospital of Tongji University

linchering@163.com+86 138 1634 3692

Outcome results

None listed

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