Evaluation of the Effect of Injectable Neucardin on Cardiac Function and Reversal Ventricular Remodeling in Patients With Chronic Systolic Heart Failure
Chronic Systolic Heart Failure
About this trial
This is an interventional treatment trial for Chronic Systolic Heart Failure focused on measuring CHF Neucardin
Eligibility Criteria
Inclusion Criteria: 18-75 years, male or female; Definite diagnosis of heart failure for 6 months or more, current stable disease, NYHA class II-III, left ventricular ejection fraction (LVEF) ≤ 40%(echocardiographic modified Simpson's method measurement ≤ 40% at screening, and CMR measurement ≤ 40% at baseline); NT-proBNP ≤1700 pg/ml in males and ≤4000pg/ml in females (detected by Roche kit in central laboratory); Receiving standard basic treatment for heart failure for at least 3 months, and did not change the type and dose of heart failure treatment drugs within 1 month; Understand and sign the informed consent form. Exclusion Criteria: Unable to receive CMR examination, such as patients with pacemakers, ICDs, CRTs, or other similar devices contraindicated for CMR, claustrophobia, atrial fibrillation during the screening period, or inability to cooperate with air-closed activities required for CMR testing; Hypertrophic cardiomyopathy with left ventricular outflow tract obstruction, constrictive pericarditis, significant and uncorrected valvular heart disease, severe valvular regurgitation or severe stenosis, congenital heart disease requiring surgical treatment but not surgical treatment, primary pulmonary hypertension or secondary severe pulmonary hypertension (≥ 70 mmHg), and right heart failure due to pulmonary disease; Patients suffering from proliferative glands or adenomas with endocrine activity which may affect cardiac function or endocrine function, such as pheochromocytoma, thyromegaly, etc. (patients with euthyroid thyroid nodules do not need to be excluded); LVESVi less than 135 ml/m2 at baseline; Prepare to install pacemaker, ICD, CRT or other similar devices within 6 months; History of heart transplantation, use of ventricular assist devices (VADs) or preparation for heart transplantation, VADs; Diagnosis of peripartum or chemotherapy-induced cardiomyopathy within the past 12 months; Subjects with chronic heart failure with acute hemodynamic disturbance or acute decompensation within the past 1 month (symptoms and signs prove that chronic heart failure is aggravated and intravenous drug therapy is required); Angina pectoris within the past 3 months; Myocardial infarction, cerebrovascular accident, revascularization (PCI or other surgery), cardiac surgery, carotid artery or other large vessel surgery within the past 6 months; Serious ventricular arrhythmias (sustained ventricular tachycardia or other conditions that the investigator considers necessary to exclude); Clinical diagnosis of pericardial effusion, pleural effusion or imaging showed pericardial effusion (greater than 50ml or 3 mm or a small amount or more) or pleural effusion (greater than 200ml or 10 mm); Liver and kidney dysfunction and chronic liver disease may have a potential impact on liver function (such as active chronic hepatitis, etc.), non-heart failure causes of bilirubin or alkaline phosphatase > 2 times the upper limit of normal, aspartate aminotransferase and/or alanine aminotransferase > 3 times the upper limit of normal, eGFR calculated using MDRD method < 30 ml/min/1.73 m2; Systolic blood pressure < 90 mmHg or > 160 mmHg; Serum K + < 3.2 mmol/L or > 5.5 mmol/L; Women of childbearing potential who plan to become pregnant within 2 years (women of childbearing potential are defined as all women with physical ability to become pregnant), pregnant or lactating women; Previous history of cancer or current cancer, or pathological examination confirmed precancerous lesions (Such as ductal carcinoma in situ of the breast, or atypical hyperplasia of the cervix), or through the examination (physical examination, X-ray examination or B ultrasound examination or other means) found in vivo malignant mass subjects; The investigator judges that the survival time is expected to be less than 6 months; Participated in any drug clinical trials within the first 3 months; Severe neurological disease (Alzheimer's disease, progressive parkinsonism); Subjects who are unable to complete this study or fail to comply with the requirements of this study (due to administrative reasons or other reasons), as judged by the investigator.
Sites / Locations
- Beijing Chao-Yang Hospital , Capital Medical University
- Beijing Anzhen Hospital , Capital Medical University
- Beijing Friendship Hospital , Capital Medical University
- Peking University First Hospital
- Peking University People's Hospital
- The First Medical Center of General Hospital of Chinese People's Liberation Army
- Fuwai Hospital Chinese Academy of Medical Sciences
- Chongqing Emergency Medical Center (Chongqing Fourth People's Hospital)
- Chongqing University Three Gorges Hospital
- Longyan First Hospital
- Xiamen University Affiliated Cardiovascular Hospital
- First Affiliated Hospital of Sun Yat-sen University
- Guangdong Jieyang People's Hospital
- Liuzhou worker's hospital
- People's Hospital of Guangxi Zhuang Autonomous Region
- Haikou People's Hospital
- Hainan Provincial People's Hospital
- Affiliated Hospital of Hebei University
- The First Hospital of Hebei Medical University
- Daqing Oilfield General Hospital
- The First Affiliated Hospital of Harbin Medical University
- Anyang People's Hospital (Anyang Central Hospital)
- Huaihe Hospital of Henan University
- First Affiliated Hospital of Henan University of Science and Technology
- Luoyang Central Hospital
- Nanyang Central HospitalRecruiting
- Nanyang First People's Hospital
- General Hospital of Puyang Oilfield
- Sanmenxia Central Hospital
- First People's Hospital of Shangqiu
- The First Affiliated Hospital of Xinxiang Medical College
- First Affiliated Hospital of Zhengzhou University
- Chenzhou First People's Hospital
- People's Hospital of Wuhan University
- Zhongnan Hospital of Wuhan University
- Xiangyang Central Hospital
- People's Hospital of Hunan Provincial
- South China University Affiliated South China Hospital
- The Second Affiliated Hospital of Nanhua University
- Yueyang Central Hospital
- Jiangxi Provincial People's Hospital
- Changzhou No.2 People's HospitalRecruiting
- Huai'an First People's Hospital
- The Second Affiliated Hospital of Nanjing Medical University
- Zhongda Hospital Southeast University
- The First Affiliated Hospital of Soochow University
- Affiliated Hospital of Xuzhou Medical University
- China-Japan Union Hospital of Jilin University
- Jilin University Second Hospital
- The First Hospital of Jilin University
- Benxi Central Hospital
- The First Affiliated Hospital of Dalian Medical University
- Zhongshan Hospital Affiliated to Dalian University
- Shengjing Hospital of China Medical University
- The First Hospital of China Medical University
- Heze Municipal Hospital
- Jinan Central Hospital
- Qilu Hospital of Shandong University
- Shandong Province Qianfoshan Hospital
- Linyi People's Hospital
- Tai'an City Central Hospital
- Zibo Municipal Hospital
- Putuo District Central Hospital of Shanghai
- Shanxi Provincial Cardiovascular HospitalRecruiting
- The First Hospital of Shanxi Medical University
- The First Affiliated Hospital of Xi 'an Jiaotong University
- Xi'an Gaoxin Hospital
- Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine
- Xianyang Hospital of Yan 'an UniversityRecruiting
- Mianyang Central Hospital
- The First Affiliated Hospital of Dali University
- Fuwai Yunnan Cardiovascular Hospital
- The First People's Hospital of Yunnan Province
- The First Affiliated Hospital , Zhejiang University School of Medicine
- The Second Affiliated Hospital of Zhejiang University School of Medicine
- Affiliated Hospital of Hangzhou Normal University
- Sir Run Run Shaw Hospital
- Jiaxing First Hospital
- Ningbo Huamei Hospital, University of Chinese Academy of Sciences (Ningbo Second Hospital)
- The First Hospital of Ningbo
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Investigational drug group
placebo group
Neucardin+standard basic therapeutic medication
Placebo + standard basic therapeutic medication