HFrEF
Conditions
Interventions
Experimental group1:SAL007 0.03mg/kg
Experimental group2:SAL007 0.09mg/kg
Experimental group3:SAL007 0.27mg/kg
Experimental group4:SAL007 0.54mg/kg
Experimental group5:SAL007 1.08mg/kg
Sponsors
Zhongda Hospital Southeast University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 80 years; 2.Body mass index >=18 kg/m^2 and =Grade 3 valvular disease on 2D-TTE.; 6.Subjects must be taking clinician-directed appropriate pharmacological therapy for HF as per the 2018 Chinese heart failure guidelines and at investigator determined discretion at stable doses (except for diuretics) for at least 2 months prior to informed consent; 7.Subject is willing and able to comply with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1.Any past participation in a study that has investigated the NRG-1 pathway (e.g., Neucardin, cimaglermin); 2.Heart failure due to hypertrophic cardiomyopathy, restrictive cardiomyopathy, arrhythmogenic right ventricular dysplasia (ARVD), stress-induced ("Takotsubo") cardiomyopathy, chemotherapy-induced cardiomyopathy, peripartum cardiomyopathy, infiltrative or inflammatory cardiomyopathies, and primary valvular disease; 3.Diagnosed with medically documented acute coronary syndrome within 3 months of screening or a medically documented acute myocardial infarction within 6 months of screening; 4.Cardiac surgery, coronary artery revascularization, percutaneous coronary intervention, or valvuloplasty within 3 months prior to screening; 5.Any major surgical procedure within 1 month prior to screening or planned surgical procedure during the study period; 6.Sustained systolic BP 450 ms for males or QTcF >470 ms for females during screening and/or prior to randomization; 10. Clinically significant renal dysfunction as measured by the estimated glomerular filtration rate of 2.0 x the upper limit of normal (ULN), alkaline phosphatase > 2.0 x ULN, AST >2.0 x ULN, or GGT >2.0 x ULN or serum bilirubin >= 1.2 x ULN at screening, or a clinically significant change in liver function between screening and baseline; 12. Subjects with alteration of the coagulation panel (international normalized ratio [INR]) and/or prothrombin time (PT) >=1.5 x the ULN; activated partial thromboplastin time (aPTT) >=1.5 x ULN, or serum albumin 2.5x ULN per institutional standards at screening; 14. Screening hemoglobin <9.0 g/dL, platelets <100x109 /mL, ANC <1500/mL; 15. Any subject who by Investigators judgement, has a significant hematuria or proteinuria at s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vital signs;Physical examination; | — |
Countries
China
Contacts
Public ContactChen Yuchen
Outcome results
None listed