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Observation on the Efficacy and Mechanism Research of Recombinant Human Brain Natriuretic Peptide in Acute Decompensated Heart Failure Complicated with Diuretic Resistance Based on RASS System and ENaC Pathway

Based on the RASS system and the ENaC pathway, an investigation on the therapeutic effect and mechanism of recombinant human brain natriuretic peptide in acute decompensated heart failure with resistance to diuretics: A prospective, single-arm, observational study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109191
Enrollment
Unknown
Registered
2025-09-15
Start date
2025-09-15
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Acute decompensated heart failure combined with diuretic resistance

Interventions

Observation group:None

Sponsors

The Affiliated Panyu Central Hospital, Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Age: 18 - 85 years old; 2.Meets the diagnostic criteria for acute decompensated heart failure as stipulated in the "Chinese Guidelines for Diagnosis and Treatment of Heart Failure 2024": presenting with symptoms and signs of acute heart failure, including but not limited to exertional dyspnea, nocturnal paroxysmal dyspnea, sitting-up breathing, fatigue, fluid retention (such as pulmonary edema or peripheral edema), etc., with NYHA cardiac function classification of III-IV grade, for patients under 50 years old, NT-proBNP level > 450 ng/L, for those aged 50-75 years old, > 900 ng/L, for those over 75 years old, > 1800 ng/L, and > 1200 ng/L when there is renal dysfunction; 3.Meets the diagnostic criteria for diuretic resistance as stipulated in the "Chinese Expert Consensus on Diagnosis and Management of Diuretic Resistance in Heart Failure Patients 2024", where after daily intravenous use of furosemide at a dose of = 80 mg or using an equivalent dose of other diuretics, the appropriate urine output (0.5 - 1.0 mL/kg/h) cannot be achieved or the daily weight loss is less than 0.5 - 1.0 kg; 4.Judged by the investigator that recombinant human brain natriuretic peptide treatment is necessary; 5.The patient or the legal representative of the patient consents to participate in the trial and signs the informed consent form;

Exclusion criteria

Exclusion criteria: 1.There is a risk of developing cardiogenic shock, and the dosage of vasoactive drugs required is greater than 0.4ug/kg/min; 2.Patients who the researchers determine are not suitable for using vasodilator drugs, such as those with severe valve stenosis, restrictive or obstructive cardiomyopathy, restrictive pericarditis, pericardial tamponade or other conditions where cardiac output relies on venous return or is suspected of having low cardiac filling pressure; 3.Uncorrectable hypotension, with systolic blood pressure lower than 90mmHg after treatment with vasopressors and mean arterial pressure still lower than 65mmHg. 4.Patients who did not reach diuretic resistance before enrollment but have already used recombinant human brain natriuretic peptide. 5) Patients known or suspected to be allergic to the drugs or ingredients described in this protocol. 5.Patients known or suspected to be allergic to the drugs or ingredients described in this protocol. 6.Patients with an estimated survival time of less than 24 hours. 7.Patients participating in another clinical trial simultaneously. 8.Social and physiological vulnerable groups, such as children, pregnant women, those with mental disorders, those with cognitive impairments, end-stage patients, prisoners, employees and students, etc. 9.Any other situation that the researcher considers may pose risks to the patient.

Design outcomes

Primary

MeasureTime frame
NT-proBNP;

Secondary

MeasureTime frame
ENaC-a;Angiotensin II;NCCT;ENaC-?;aldosterone;

Countries

China

Contacts

Public ContactYe Jingkun

The Affiliated Panyu Central Hospital, Guangzhou Medical University

yipchingkwan@163.com+86 20 3485 9350

Outcome results

None listed

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