Acute heart failure
Conditions
Interventions
Experimental drug dose 1 group:Combination therapy with recombinant human brain natriuretic peptide was administered intravenously at a rate of 0.01 µ g/kg · min. Continuous treatment for at least 5 d
Experimental drug dose 2 group:Combination therapy with recombinant human brain natriuretic peptide is performed on basic treatment, starting with continuous intravenous infusion of 0.01 µ g/kg · min
Sponsors
Fuwai Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18 to 75 years old (including the critical value), gender not limited. 2. Diagnosed with acute heart failure in accordance with the National Heart Failure Guidelines 2023; 3. Those diagnosed with acute heart failure within less than 24 hours before randomization; 4. Before screening and randomization, there was dyspnea at rest or at minimum activity (defined as breathing difficulties in daily states such as sitting, lying flat, speaking, and eating); 5. At least one of the following conditions must be met: jugular vein distension, pulmonary rales, or edema of the lower extremities; 6. Chest X-rays or CT scans suggest pulmonary congestion or pulmonary edema; 7. NYHA classification of cardiac function: Grade ? to ?; 8. During screening, NT - proBNP>=600ng/L, and when accompanied by atrial fibrillation, NT - proBNP>=900ng/L; 9. The subjects voluntarily signed the informed consent form and were willing and able to comply with all the requirements of the trial.
Exclusion criteria
Exclusion criteria: 1.Those with an expected survival period of less than 6 months; 2. Those with an expected hospitalization time of no more than 24 hours; 3. Have used the following drugs: Levosimendan was used within 5 days prior to randomization; Within 24 hours before randomization, use milrinone, amrinone, or any recombinant human brain natriuretic peptide; Three hours before randomization, vasodilators (nitroglycerin, nitrates), intravenous injection of dobutamine and dopamine were used. 4. Cardiogenic shock occurred during the screening process; 5. Patients who are not suitable for using vasodilator drugs, such as: Severe valvular stenosis, hypertrophic obstructive cardiomyopathy or restrictive cardiomyopathy, constrictive pericarditis, pericardial tamponade, persistent ventricular tachycardia (ventricular rate > 110 beats per minute) or recurrent ventricular fibrillation, significant bradycardia (persistent ventricular rate 160mmol/L, and/or K+ 5.5mmol/L; Liver function impairment not caused by heart failure: ALT and/or AST > 3 times the upper limit of the normal range, and/or bilirubin > 1.5 times the upper limit of the normal range; Hemoglobin <9g/dL (<5.6mmol/L); 12. Those with severe mental and psychological disorders, cognitive impairments, or a history of mental illness; 13. Individuals with a known severe allergic constitution, or those who have experienced severe drug or food allergic reactions in the past, or those known to be allergic to recombinant human brain natriuretic peptide or its components; 14. Patients who are pregnant, breastfeeding or planning to become pregnant; 15. Have participated in other clinical studies and received trial interventions (such as trial drugs or medical devices, etc.) within 30 days prior to signing the informed consent form, or are still within the visit period of other clinical studies; 16. The researcher determines any other circumstances that are not suitable for conducting this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24 hours after the start of medication in Group 2, the improvement rate of respiratory distress reported by the subjects on the 7-level Likert scale # was evaluated;The percentage change of NT proBNP from baseline at 72 hours after the start of medication in both groups.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes in NT pro BNP levels at 2 hours, 6 hours, 24 hours, 48 hours, 120 hours, and 168 hours * after the start of medication in the two groups of subjects compared to baseline.;The proportion of subjects in both groups who showed a decrease of = 30% in NT pro BNP compared to baseline at 2 and 6 hours after starting medication.;The proportion of subjects in the two groups who showed improvement in respiratory distress at 4h, 12h, 48h, 72h, 96h, 120h, 144h *, and 168h * after starting medication (Likert scale # 7).; At 12h, 24h, 48h, 72h, 96h, 120h, 144h *, and 168h * after the start of medication, the overall clinical symptoms reported by the two groups of subjects (lower limb edema, hepatomegaly, oliguria, ascites, pulmonary rales, and jugular vein engorgement, totaling 6 abnormal signs) were evaluated based on the improvement degree rating (7-level Likert scale #).;48 hours after the start of medication, the changes in E/e 'measured by echocardiography compared to baseline were observed in both groups of subjects.;The changes in left ventricular ejection fraction (LVEF) and cardiac output (CO) compared to baseline were measured by echocardiography at 6h, 12h, 24h, 48h, 72h, 168h *, and on the 30th day after the start of medication in the two groups of subjects.;Within 24 hours after the start of medication, the fluid intake and output of the two groups of subjects. The liquid output is the urine output, and the input is the total amount of liquid intake and intravenous infusion.;Changes in urine volume within 0-8h, 8-16h, 16-24h after the start of medication for the two groups of subjects, as well as changes in 24-hour urine volume before and within 7 days after the start of medication.;Two groups of subjects were measured for changes in blood urea nitrogen (BUN) and creatinine (Scr) compared to baseline before and 24, 72, and 168 hours after the start of medication, and the changes in renal function were re evaluated 30 days after the start of medication.;Ch | — |
Countries
China
Contacts
Public ContactZhang Yuhui
Fuwai Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed