Evaluating a new treatment for chronic heart failure

A Multi-center, Randomized, Double-blined, Placebo Parallel Controlled Phase III Clinical Trial to Evaluate the Effect of Injectable Neucardin on the Mortality of Subjects With Chronic Systolic Heart Failure on Standard HF Therapy.

This study is testing whether a new treatment called rhNRG-1 can help people with chronic heart failure live longer and improve their heart function.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1600 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zensun Sci. & Tech. Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 65 sites (Beijing, Beijing and 64 other locations)
• Trial ID: NCT03388593 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness of recombinant human neuregulin-1β (rhNRG-1) in reducing mortality rates among patients with chronic heart failure. Participants will have a baseline NT-proBNP level between 600 pg/ml and 1700 pg/ml and will be classified as NYHA class II or III. The study will involve administering rhNRG-1 or a placebo to evaluate its impact on heart function and overall survival. Previous trials have indicated that rhNRG-1 may enhance heart function and reverse left ventricular remodeling.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with chronic heart failure classified as NYHA class II or III and specific NT-proBNP levels.

Not a fit: Patients with NYHA class I or IV heart failure or those with NT-proBNP levels outside the specified range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly lower the death rate in patients suffering from chronic heart failure.

How similar studies have performed: Previous studies have shown promising results with rhNRG-1, indicating its potential effectiveness in treating chronic heart failure.

Eligibility criteria

Inclusion Criteria:

* 1. Age between 18 and 75, gender balance (no more than 960 subjects of either gender in total 1600 subjects).
* 2. Left ventricular ejection fraction (LVEF)≤40% (ECHO).
* 3. Subjects with chronic heart failure (NYHA class II OR III ).
* 4. 600 pg/ml ≤NT-proBNP≤1700 pg/ml ( by Roche assay Kit in central lab).
* 5. Diagnosed as chronic systolic heart failure (history, symptoms, signs), and in stable condition in the last one month.
* 6. Receiving standard therapy for chronic heart failure, reach target dose or max tolerable dose for one month, or has not changed the dose for one month before randomization.
* 7. Capable of signing the informed consent form.

Exclusion Criteria:

* 1. New chronic heart failure patients, or patients receiving standard therapy on chronic heart failure for less than 3 months.
* 2. NYHA functional class I OR IV.
* 3. NT-proBNP \< 600 pg/ml OR NT-proBNP\>1700 pg/ml (by Roche assay Kit in central lab).
* 4. Patients with hypertrophic cardiomyopathy, rheumatic heart disease, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, primary or secondary severe pulmonary artery hypertension.
* 5. Ischemic heart failure without recanalization or with recanalization in recent six months.
* 6. Acute MI in the last 3 months.
* 7. Unstable angina.
* 8. Patients with acute pulmonary edema or acute hemodynamic disorder.
* 9. Chronic heart failure patients with acute hemodynamic disorder or acute decompensation in the last 1 month (symptoms and signs suggest worsening chronic heart failure and may require intravenous drug therapy).
* 10. Patients with right heart failure caused by pulmonary disease.
* 11. Patients diagnosed with pericardial effusion (\>50 ml) or pleural effusion(\>200 ml), or evidenced by Echocardiogram.
* 12. Cardiac surgery or cerebrovascular accident within recent six months.
* 13. Preparing for heart transplantation or CRT, or has received CRT.
* 14. Serious ventricular arrhythmia (sustained ventricular tachycardia or frequent paroxysmal ventricular tachycardia).
* 15.Diagnosis of perinatal or chemotherapy-induced cardiomyopathy in last 12 months.
* 16. Serious hepatic or renal dysfunction (bilirubin 1.5 times above the normal upper limit, AST or ALT 2 times above the normal upper limit, serum creatinine\>2.0mg/dL, HBV or HCV positive).
* 17. Serum potassium \<3.2 mmol/L or \>5.5 mmol/L.
* 18. Systolic blood pressure \<90mmHg or \>160mmHg.
* 19. Women of childbearing age who have a pregnancy plan within 2 years (women of childbearing age are defined as women who have a pregnancy physiology).
* 20. Pregnant or lactating women.
* 21. Patients who participated in any clinical trial in the recent three months.
* 22. Subject with a life expectancy less than 6 months as assessed by the investigator.
* 23. Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism),lower limb defects, or deaf-mute.
* 24. History of any malignancy or suffering from cancer, or biopsy proven pre-malignant condition (e.g., DICS or cervical atypia).
* 25. Evidence (physical examination, chest X-ray (CXR), ECHO or other tests) shows some active malignancy or adenoidal hypertrophy or neoplasm that has an effect on heart function or the endocrine system, e.g., pheochromocytoma or hyperthyroidism (Thyroid nodules with normal thyroid function do not need to be excluded).
* 26. As judged by the investigator that the subject cannot complete the study or adhere to the study requirements (due to the management reasons or others).

Where this trial is running

Beijing, Beijing and 64 other locations

• Beijing Hospital of Traditional Chinese Medicine — Beijing, Beijing, China (Recruiting)
• Navy General Hospital — Beijing, Beijing, China (Recruiting)
• Beijing Jingmei Group General Hospital — Beijing, Beijing, China (Recruiting)
• Fuwai Hospital and Cardiovascular Institute, Chinese Academy of Medical Sciences — Beijing, Beijing, China (Recruiting)
• Affiliated Hospital of Chongqing Three Gorges Medical College — Chongqing, Chongqing, China (Recruiting)
• Chongqing Emergency Medical Center — Chongqing, Chongqing, China (Recruiting)
• Chongqing Three Gorges Central Hospital — Chongqing, Chongqing, China (Recruiting)
• Sun Yai-sen Memorial hospital Sun Yai-sen University — Guangzhou, Guangdong, China (Recruiting)
• Guangdong Second Provincial Central Hospital — Guangzhou, Guangdong, China (Recruiting)
• Guangzhou Panyu Central Hospital — Guangzhou, Guangdong, China (Recruiting)
• Affiliated Hospital of Guangdong Medical University — Zhanjiang, Guangdong, China (Not_yet_recruiting)
• The Fifth Affiliated Hospital Sun Yat-Sen University — Zhuhai, Guangdong, China (Recruiting)
• The First People's Hospital of Zunyi — Zunyi, Guizhou, China (Recruiting)
• Haikou People's Hospital — Haikou, Hainan, China (Recruiting)
• The Third People's Hospital of Hainan Province — Sanya, Hainan, China (Recruiting)
• HanDan Central Hospital — Handan, Hebei, China (Recruiting)
• First Hospital of Handan — Handan, Hebei, China (Recruiting)
• 980 Hospital of PLA Joint Logistics Support Force (Bethune International Peace Hospital) — Shijiazhuang, Hebei, China (Recruiting)
• The Second Affiliated Hospital of Xingtai Medical College — Xingtai, Hebei, China (Recruiting)
• Xingtai People's Hospital — Xingtai, Hebei, China (Recruiting)
• The Third Affiliated Hospital of Qiqihar Medical University — Qiqihar, Heilongjiang, China (Recruiting)
• Huaihe Hospital of Henan University — Kaifeng, Henan, China (Recruiting)
• The First People's Hospital of Luoyang — Luoyang, Henan, China (Recruiting)
• Puyang Oilfield General Hospital — Puyang, Henan, China (Recruiting)
• The First People's Hospital of Xinxiang — Xinxiang, Henan, China (Recruiting)
• Pepole's hospital of Xinzheng — Xinzheng, Henan, China (Recruiting)
• Zhengzhou First People's Hospital — Zhengzhou, Henan, China (Recruiting)
• Luoyang center hospital — Zhengzhou, Henan, China (Recruiting)
• Henan Provincial Chest Hospital — Zhengzhou, Henan, China (Recruiting)
• Xiangya Hospital Central South University — Changsha, Hunan, China (Recruiting)
• Hunan Provincial People's Hospital — Changsha, Hunan, China (Recruiting)
• The Second Hospital. University of South China — Hengyang, Hunan, China (Recruiting)
• The First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science & Technology — Baotou, Inner Mongolia, China (Recruiting)
• Chifeng Municipal Hospital — Chifeng, Inner Mongolia, China (Recruiting)
• The Affiliated Hospital of Xuzhou Medical College — Xuzhou, Jiangsu, China (Recruiting)
• Jiujiang Hospital Affiliated to Nanchang University — Jiujiang, Jiangxi, China (Recruiting)
• Jilin Academy of Traditional Chinese Medicine — Chang Chun, Jilin, China (Recruiting)
• Affiliated Hospital of Changchun University of Chinese Medicine — Changchun, Jilin, China (Recruiting)
• Jilin University Sino-Japanese Friendship Hospital — Changchun, Jilin, China (Recruiting)
• The First Affiliated Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
• Meihekou Central Hospital — Meihekou, Jilin, China (Recruiting)
• Siping Central People's Hospital — Siping, Jilin, China (Recruiting)
• Tonghua Central Hospital — Tonghua, Jilin, China (Recruiting)
• The People's Hospital of Liaoning Province — Shenyang, Liaoning, China (Recruiting)
• Shengjing Hospital Affiliated to China Medical University — Shenyang, Liaoning, China (Recruiting)
• The Affiliated Hospital of Shaanxi University of Chinese Medicine — Xianyang, Shaanxi, China (Recruiting)
• Jinan Central Hospital — Jinan, Shandong, China (Recruiting)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
• Central hospital of minhang District — Shanghai, Shanghai, China (Recruiting)
• The Sixth People's Hospital, Shanghai Jiaotong University — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Runlin Gao, Ph.D,MD — Fuwai Hospital and Cardiovascular Institute, Chinese Academy of Medical Sciences
• Study coordinator: Xiaorui Wang, Ph.D

Conditions Chronic Heart Failure; chronic heart failure; neuregulin; mortality