Survival Study of the Recombinant Human Neuregulin-1β in Subjects With 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.
1 other identifier
interventional
1,600
1 country
65
Brief Summary
The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure subjects with baseline NT-proBNP level between 600 pg/ml and 1700 pg/mL and NYHA class II to III.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2018
Longer than P75 for phase_3
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2017
CompletedFirst Posted
Study publicly available on registry
January 3, 2018
CompletedStudy Start
First participant enrolled
July 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedFebruary 1, 2024
January 1, 2024
7.5 years
December 19, 2017
January 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause mortality
Including deaths from cardiovascular and non-cardiovascular causes, Log-Rank test was used for comparison between groups, and Kaplan-Meier survival curves were plotted; COX proportional hazard model was used to estimate the HR and its 95% confidence interval.
1 year
Secondary Outcomes (7)
Mortality caused by cardiovascular events
1 year
All-cause mortality of female subjects
1 year
All-cause mortality of male subjects
1 year
Percentage of all-cause re-hospitalization
1 year
Percentage of Participants with re-hospitalization caused by worsening heart failure
1 year
- +2 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo in addition to standard therapy
rhNRG-1
EXPERIMENTALrhNRG-1 in addition to standard therapy
Interventions
10 hours per day i.v drip for the first 10 days (0.6ug/kg/day), followed by weekly 10 minutes i.v bolus (0.8ug/kg/day), from the 3rd week for 23 weeks
10 hours per day i.v drip for the first 10 days (0ug/kg/day), followed by weekly 10 minutes i.v bolus (0ug/kg/day), from the 3rd week for 23 weeks
Eligibility Criteria
You may qualify if:
- \. Age between 18 and 75, gender balance (no more than 960 subjects of either gender in total 1600 subjects).
- \. Left ventricular ejection fraction (LVEF)≤40% (ECHO).
- \. Subjects with chronic heart failure (NYHA class II OR III ).
- \. 600 pg/ml ≤NT-proBNP≤1700 pg/ml ( by Roche assay Kit in central lab).
- \. Diagnosed as chronic systolic heart failure (history, symptoms, signs), and in stable condition in the last one month.
- \. 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.
- \. Capable of signing the informed consent form.
You may not qualify if:
- \. New chronic heart failure patients, or patients receiving standard therapy on chronic heart failure for less than 3 months.
- \. NYHA functional class I OR IV.
- \. NT-proBNP \< 600 pg/ml OR NT-proBNP\>1700 pg/ml (by Roche assay Kit in central lab).
- \. Patients with hypertrophic cardiomyopathy, rheumatic heart disease, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, primary or secondary severe pulmonary artery hypertension.
- \. Ischemic heart failure without recanalization or with recanalization in recent six months.
- \. Acute MI in the last 3 months.
- \. Unstable angina.
- \. Patients with acute pulmonary edema or acute hemodynamic disorder.
- \. 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).
- \. Patients with right heart failure caused by pulmonary disease.
- \. Patients diagnosed with pericardial effusion (\>50 ml) or pleural effusion(\>200 ml), or evidenced by Echocardiogram.
- \. Cardiac surgery or cerebrovascular accident within recent six months.
- \. Preparing for heart transplantation or CRT, or has received CRT.
- \. Serious ventricular arrhythmia (sustained ventricular tachycardia or frequent paroxysmal ventricular tachycardia).
- Diagnosis of perinatal or chemotherapy-induced cardiomyopathy in last 12 months.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (65)
Beijing Hospital of Traditional Chinese Medicine
Beijing, Beijing Municipality, 100010, China
Navy General Hospital
Beijing, Beijing Municipality, 100048, China
Beijing Jingmei Group General Hospital
Beijing, Beijing Municipality, China
Fuwai Hospital and Cardiovascular Institute, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Affiliated Hospital of Chongqing Three Gorges Medical College
Chongqing, Chongqing Municipality, 404000, China
Chongqing Emergency Medical Center
Chongqing, Chongqing Municipality, China
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, China
Sun Yai-sen Memorial hospital Sun Yai-sen University
Guangzhou, Guangdong, 510120, China
Guangdong Second Provincial Central Hospital
Guangzhou, Guangdong, 510317, China
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong, 511400, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524001, China
The Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai, Guangdong, China
The First People's Hospital of Zunyi
Zunyi, Guizhou, 133012, China
Haikou People's Hospital
Haikou, Hainan, China
The Third People's Hospital of Hainan Province
Sanya, Hainan, China
HanDan Central Hospital
Handan, Hebei, 056001, China
First Hospital of Handan
Handan, Hebei, 056002, China
980 Hospital of PLA Joint Logistics Support Force (Bethune International Peace Hospital)
Shijiazhuang, Hebei, 05000, China
The Second Affiliated Hospital of Xingtai Medical College
Xingtai, Hebei, 054000, China
Xingtai People's Hospital
Xingtai, Hebei, 054000, China
The Third Affiliated Hospital of Qiqihar Medical University
Qiqihar, Heilongjiang, 161002, China
Huaihe Hospital of Henan University
Kaifeng, Henan, 475000, China
The First People's Hospital of Luoyang
Luoyang, Henan, China
Puyang Oilfield General Hospital
Puyang, Henan, 457001, China
The First People's Hospital of Xinxiang
Xinxiang, Henan, China
Pepole's hospital of Xinzheng
Xinzheng, Henan, 451150, China
Zhengzhou First People's Hospital
Zhengzhou, Henan, 450004, China
Luoyang center hospital
Zhengzhou, Henan, 471099, China
Henan Provincial Chest Hospital
Zhengzhou, Henan, China
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
The Second Hospital. University of South China
Hengyang, Hunan, 421001, China
The First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science & Technology
Baotou, Inner Mongolia, China
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, 024000, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
Jiujiang Hospital Affiliated to Nanchang University
Jiujiang, Jiangxi, 332000, China
Affiliated Hospital of Changchun University of Chinese Medicine
Changchun, Jilin, 130021, China
Jilin Academy of Traditional Chinese Medicine
Changchun, Jilin, 130021, China
Jilin University Sino-Japanese Friendship Hospital
Changchun, Jilin, China
The First Affiliated Hospital of Jilin University
Changchun, Jilin, China
Meihekou Central Hospital
Meihekou, Jilin, 135000, China
Siping Central People's Hospital
Siping, Jilin, China
Tonghua Central Hospital
Tonghua, Jilin, 134000, China
The People's Hospital of Liaoning Province
Shenyang, Liaoning, 110016, China
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, China
The Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, Shaanxi, 712000, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Central hospital of minhang District
Shanghai, Shanghai Municipality, 200000, China
The Sixth People's Hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, shanghai, China
Shanghai Oriental hospital
Shanghai, Shanghai Municipality, China
Shanghai Yangpu District Central Hospital
Shanghai, Shanghai Municipality, China
The Central Hospital of Putuo District, Shanghai
Shanghai, Shanghai Municipality, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
Shanxi cardiovascular disease hospital
Taiyuan, Shanxi, 030024, China
Taiyuan City Central Hospital
Taiyuan, Shanxi, China
Pepole's hospital of DeYang city
Deyang, Sichuan, 618000, China
The Second People's Hospital of Neijiang
Neijiang, Sichuan, China
Wuqing pepole's hospital
Tianjing, Tianjing, 300000, China
Fourth Affiliated Hospital of Xinjiang Medical University
Xinjiang, Xinjiang, 830054, China
The Third People's Hospital of Yunnan Province
Kunming, Yunnan, 650011, China
The Second Hospital of Kunming Medical College
Kunming, Yunnan, China
Shulan (Hangzhou) Hospital
Hangzhou, Zhejiang, 310000, China
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, China
Quzhou people's hospital
Quzhou, Zhejiang, China
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Runlin Gao, Ph.D,MD
Fuwai Hospital and Cardiovascular Institute, Chinese Academy of Medical Sciences
Central Study Contacts
Runlin Gao, Ph.D,MD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2017
First Posted
January 3, 2018
Study Start
July 23, 2018
Primary Completion
February 1, 2026
Study Completion
February 1, 2026
Last Updated
February 1, 2024
Record last verified: 2024-01