Survival Study of the Recombinant Human Neuregulin-1β in Subjects With Chronic Heart Failure.

January 30, 2024 updated by: Zensun Sci. & Tech. Co., Ltd.

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The mortality of chronic heart failure patients remains high, in spite of current treatment. RhNRG-1(recombinant human neuregulin-1)directly work on the cardiomyocyte and restored the normal structure and function of it. Both the preclinical trials, phase II clinical trials and already completed phase III clinical trails have confirmed that rhNRG-1 effectively enhance the heart function, reverse the remodeling of left ventricular, and reduce all-cause mortality in heart failure animals and humans. More importantly, rhNRG-1 can significantly reduce the mortality of heart failure subjects with baseline NT-proBNP level ≤1600 fmol/mL and NYHA class II to III. In this phase III study, the investigators will further confirm the 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Runlin Gao, Ph.D,MD

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100048
        • Recruiting
        • Navy General Hospital
        • Contact:
          • Tianchang Li
        • Principal Investigator:
          • Tianchang Li
      • Beijing, Beijing, China, 100010
        • Recruiting
        • Beijing Hospital of Traditional Chinese Medicine
        • Contact:
          • Hongxu Liu
        • Principal Investigator:
          • Hongxu Liu
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Jingmei Group General Hospital
        • Contact:
          • Jianping Luo
        • Principal Investigator:
          • Jianping Luo
      • Beijing, Beijing, China
        • Recruiting
        • Fuwai Hospital and Cardiovascular Institute, Chinese Academy of Medical Sciences
        • Contact:
          • Jian Zhang, MD, Ph.D
          • Phone Number: 86-10-88398772
        • Principal Investigator:
          • Jian Zhang, MD, Ph.D
    • Chongqing
      • Chongqing, Chongqing, China, 404000
        • Recruiting
        • Affiliated Hospital of Chongqing Three Gorges Medical College
        • Contact:
          • Gang Xiong
        • Principal Investigator:
          • Gang Xiong
      • Chongqing, Chongqing, China
        • Recruiting
        • Chongqing Emergency Medical Center
        • Contact:
          • Ying Zhang
      • Chongqing, Chongqing, China
        • Recruiting
        • Chongqing Three Gorges Central Hospital
        • Contact:
          • Xiaohua Pang
        • Principal Investigator:
          • Xiaohua Pang
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Sun Yai-Sen Memorial Hospital Sun Yai-Sen University
        • Contact:
          • Jingfeng Wang
        • Principal Investigator:
          • Jingfeng Wang
      • Guangzhou, Guangdong, China, 510317
        • Recruiting
        • Guangdong second provincial central hospital
        • Contact:
          • Yuhui Li
        • Principal Investigator:
          • Yuhui Li
      • Guangzhou, Guangdong, China, 511400
        • Recruiting
        • Guangzhou Panyu Central Hospital
        • Contact:
          • Guoqin Chen
        • Principal Investigator:
          • Guoqin Chen
      • Zhanjiang, Guangdong, China, 524001
        • Not yet recruiting
        • Affiliated Hospital of Guangdong Medical University
        • Contact:
          • Jianying Chen
        • Principal Investigator:
          • Jianying Chen
      • Zhuhai, Guangdong, China
        • Recruiting
        • The Fifth Affiliated Hospital Sun Yat-Sen University
        • Contact:
          • Xiufang Lin
    • Guizhou
      • Zunyi, Guizhou, China, 133012
        • Recruiting
        • The First People'S Hospital of Zunyi
        • Contact:
          • Qianfeng Jiang
        • Principal Investigator:
          • Qianfeng Jiang
    • Hainan
      • Haikou, Hainan, China
        • Recruiting
        • Haikou People's Hospital
        • Contact:
          • Shijuan Lu
        • Principal Investigator:
          • Shijuan Lu
      • Sanya, Hainan, China
        • Recruiting
        • The Third People's Hospital of Hainan Province
        • Contact:
          • Ling Lin
        • Principal Investigator:
          • Ling Lin
    • Hebei
      • Handan, Hebei, China, 056001
        • Recruiting
        • HanDan Central Hospital
        • Contact:
          • Hongsen Tian
        • Principal Investigator:
          • Hongsen Tian
      • Handan, Hebei, China, 056002
        • Recruiting
        • First Hospital of Handan
        • Contact:
          • Xiufeng Zhao
        • Principal Investigator:
          • Xiufeng Zhao
      • Shijiazhuang, Hebei, China, 05000
        • Recruiting
        • 980 Hospital of PLA Joint Logistics Support Force (Bethune International Peace Hospital)
        • Contact:
          • Ru Leisheng
        • Principal Investigator:
          • Ru Leisheng
      • Xingtai, Hebei, China, 054000
        • Recruiting
        • The Second Affiliated Hospital of Xingtai Medical College
        • Contact:
          • Dongmei Gao
        • Principal Investigator:
          • Dongmei Gao
      • Xingtai, Hebei, China, 054000
        • Recruiting
        • Xingtai People's Hospital
        • Contact:
          • Qingmin Wei
        • Principal Investigator:
          • Qingmin Wei
    • Heilongjiang
      • Qiqihar, Heilongjiang, China, 161002
        • Recruiting
        • The Third Affiliated Hospital of Qiqihar Medical University
        • Contact:
          • Haifeng Shao
        • Principal Investigator:
          • Haifeng Shao
    • Henan
      • Kaifeng, Henan, China, 475000
        • Recruiting
        • Huaihe Hospital of Henan University
        • Contact:
          • Ruili He
        • Principal Investigator:
          • Ruili He
      • Luoyang, Henan, China
        • Recruiting
        • The First People's Hospital of Luoyang
        • Contact:
          • Qunsheng Zhang
        • Principal Investigator:
          • Qunsheng Zhang
      • Puyang, Henan, China, 457001
        • Recruiting
        • Puyang Oilfield General Hospital
        • Contact:
          • Fuxian Ren
        • Principal Investigator:
          • Fuxian Ren
        • Sub-Investigator:
          • Yu Zhao
      • Xinxiang, Henan, China
        • Recruiting
        • The First People's Hospital of Xinxiang
        • Contact:
          • Guiye Zhao
        • Principal Investigator:
          • Guiye Zhao
      • Xinzheng, Henan, China, 451150
        • Recruiting
        • Pepole's Hospital of Xinzheng
        • Contact:
          • Yanhong Li
        • Principal Investigator:
          • Yanhong Li
      • Zhengzhou, Henan, China, 450004
        • Recruiting
        • Zhengzhou First People's Hospital
        • Contact:
          • Hongwei Yu
        • Principal Investigator:
          • Hongwei Yu
      • Zhengzhou, Henan, China, 471099
        • Recruiting
        • Luoyang Center Hospital
        • Contact:
          • Shouyan Zhang
        • Principal Investigator:
          • Shouyan Zhang
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Provincial Chest Hospital
        • Contact:
          • Juan Chen
        • Principal Investigator:
          • Juan Chen
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital Central South University
        • Contact:
          • Zaixin Yu
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Provincial People's Hospital
        • Contact:
          • Jianqiang Peng
        • Principal Investigator:
          • Jianqiang Peng
      • Hengyang, Hunan, China, 421001
        • Recruiting
        • The Second Hospital. University of South China
        • Contact:
          • Gaofeng Zeng
        • Principal Investigator:
          • Gaofeng Zeng
    • Inner Mongolia
      • Baotou, Inner Mongolia, China
        • Recruiting
        • The First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science & Technology
        • Principal Investigator:
          • Xuefeng Lin
        • Contact:
          • Xuefeng Lin
      • Chifeng, Inner Mongolia, China, 024000
        • Recruiting
        • Chifeng Municipal Hospital
        • Contact:
          • Xiandong Sun
        • Principal Investigator:
          • XIANDONG SUN
    • Jiangsu
      • Xuzhou, Jiangsu, China
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical College
        • Contact:
          • Yong Xia
        • Principal Investigator:
          • Yong Xia, MD,Ph.D
    • Jiangxi
      • Jiujiang, Jiangxi, China, 332000
        • Recruiting
        • Jiujiang Hospital Affiliated to Nanchang University
        • Contact:
          • Xihu Yin
        • Principal Investigator:
          • Xihu Yin
    • Jilin
      • Chang Chun, Jilin, China, 130021
        • Recruiting
        • Jilin Academy of Traditional Chinese Medicine
        • Contact:
          • Shurong Liu
        • Principal Investigator:
          • Shurong Liu
      • Changchun, Jilin, China, 130021
        • Recruiting
        • Affiliated Hospital of Changchun University of Chinese Medicine
        • Contact:
          • Yue Deng
        • Principal Investigator:
          • Yue Deng
      • Changchun, Jilin, China
        • Recruiting
        • Jilin University Sino-Japanese Friendship Hospital
        • Contact:
          • Fanbo Meng
        • Principal Investigator:
          • Fanbo Meng
      • Changchun, Jilin, China
        • Recruiting
        • The first Affiliated Hospital of Jilin University
        • Contact:
          • Yushi Wang
        • Principal Investigator:
          • Yushi Wang
      • Meihekou, Jilin, China, 135000
        • Recruiting
        • Meihekou Central Hospital
        • Contact:
          • Jinliang Zhang
        • Principal Investigator:
          • Jinliang Zhang
      • Siping, Jilin, China
        • Recruiting
        • Siping Central People's Hospital
        • Contact:
          • Zhihua Fang
        • Principal Investigator:
          • Zhihua Fang
      • Tonghua, Jilin, China, 134000
        • Recruiting
        • Tonghua Central Hospital
        • Contact:
          • Xuxia Zhang
        • Principal Investigator:
          • Xuxia Zhang
    • Liaoning
      • Shenyang, Liaoning, China
        • Recruiting
        • Shengjing Hospital affiliated to China Medical University
        • Contact:
          • Shumei Ma
        • Principal Investigator:
          • Shumei Ma
      • Shenyang, Liaoning, China, 110016
        • Recruiting
        • The People's Hospital of Liaoning Province
        • Contact:
          • Zhanquan Li
        • Principal Investigator:
          • Zhanquan Li
    • Shaanxi
      • Xianyang, Shaanxi, China, 712000
        • Recruiting
        • The Affiliated Hospital of Shaanxi University of Chinese Medicine
        • Contact:
          • Ling Chen
        • Principal Investigator:
          • Ling Chen
    • Shandong
      • Jinan, Shandong, China, 250013
        • Recruiting
        • Jinan Central Hospital
        • Contact:
          • Wei Miao
        • Principal Investigator:
          • Wei Miao
      • Jinan, Shandong, China
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
          • Ming Zhong, MD,Ph.D
        • Principal Investigator:
          • Ming Zhong, MD,Ph.D
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Oriental Hospital
        • Contact:
          • Huimin Fan
        • Principal Investigator:
          • Huimin Fan
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Central Hospital of Minhang District
        • Principal Investigator:
          • Wei Hu
        • Contact:
          • Wei Hu
      • Shanghai, Shanghai, China, shanghai
        • Recruiting
        • The Sixth People's Hospital, Shanghai Jiaotong University
        • Contact:
          • Jingwei Pan
        • Principal Investigator:
          • Jingwei Pan
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Yangpu District Central Hospital
        • Contact:
          • Jiahong Wang
        • Principal Investigator:
          • Jiahong Wang
      • Shanghai, Shanghai, China
        • Recruiting
        • The Central Hospital of Putuo District, Shanghai
        • Contact:
          • Zongjun Liu, MD,Ph.D
        • Principal Investigator:
          • Zongjun Liu, MD,Ph.D
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Recruiting
        • Second Hospital of Shanxi Medical University
        • Contact:
          • Zhiming Yang
        • Principal Investigator:
          • Zhiming Yang
      • Taiyuan, Shanxi, China, 030024
        • Recruiting
        • Shanxi Cardiovascular Disease Hospital
        • Contact:
          • Huiyuan Han
        • Principal Investigator:
          • Huiyuan Han
      • Taiyuan, Shanxi, China
        • Suspended
        • Taiyuan City Central Hospital
    • Sichuan
      • Deyang, Sichuan, China, 618000
        • Recruiting
        • Pepole's hospital of DeYang city
        • Contact:
          • Xiaojian Deng
        • Principal Investigator:
          • Xiaojian Deng
      • Neijiang, Sichuan, China
        • Recruiting
        • The Second People's Hospital of Neijiang
        • Contact:
          • Quanwei Liu
        • Principal Investigator:
          • Quanwei Liu
    • Tianjing
      • Tianjing, Tianjing, China, 300000
        • Recruiting
        • Wuqing pepole's hospital
        • Contact:
          • Feng Ling
        • Principal Investigator:
          • Feng Ling
    • Xinjiang
      • Xinjiang, Xinjiang, China, 830054
        • Recruiting
        • Fourth Affiliated Hospital of Xinjiang Medical University
        • Contact:
          • Peng Li
        • Principal Investigator:
          • Peng Li
    • Yunnan
      • Kunming, Yunnan, China, 650011
        • Recruiting
        • The Third People's Hospital of Yunnan Province
        • Contact:
          • Yunfei Hong
      • Kunming, Yunnan, China
        • Recruiting
        • The Second Hospital of Kunming Medical College
        • Contact:
          • Wenwei Bai
        • Principal Investigator:
          • Wenwei Bai
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Shulan (Hangzhou) Hospital
        • Contact:
          • Liping Ma
        • Principal Investigator:
          • Liping Ma
      • Linhai, Zhejiang, China
        • Recruiting
        • Taizhou Hospital of Zhejiang Province
        • Contact:
          • Jianjun Jiang
        • Principal Investigator:
          • Jianjun Jiang
      • Quzhou, Zhejiang, China
        • Recruiting
        • Quzhou people's Hospital
        • Contact:
          • Xiaoming Tu
        • Principal Investigator:
          • Xiaoming Tu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo in addition to standard therapy
Drug: Placebo
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
Experimental: rhNRG-1
rhNRG-1 in addition to standard therapy
Drug: rhNRG-1
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
Other Names:
  • Neucardin™

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 1 year
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mortality caused by cardiovascular events
Time Frame: 1 year
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
All-cause mortality of female subjects
Time Frame: 1 year
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
All-cause mortality of male subjects
Time Frame: 1 year
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
Percentage of all-cause re-hospitalization
Time Frame: 1 year
The Kaplan-Meier curve was used to describe the cumulative incidence rate of the first re-hospitalization, and the differences between the two groups were compared using Log-Rank.
1 year
Percentage of Participants with re-hospitalization caused by worsening heart failure
Time Frame: 1 year
The Kaplan-Meier curve was used to describe the cumulative incidence rate of the first re-hospitalization, and the differences between the two groups were compared using Log-Rank.
1 year
Change of NT-proBNP level at the 25th week and 52th week
Time Frame: 1 year
The paired t test or signed rank sum test was used to compare the changes before and after treatment in each group, and the comparison between groups was performed by analysis of variance or Wilcoxon rank sum test.
1 year
New York Heart Association (NYHA) functional classification
Time Frame: 1 year
For the NYHA cardiac functional grading after administration, summarize the number and percentage of subjects by different study visit period, compare the efficacy differences among test groups and control groups. In addition, calculate the changes of NYHA cardiac functional grade from baseline of the subjects. The intragroup changes will be analyzed by signed-rank sum test, intergroup comparison will be conducted by Wilcoxon test.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zensun Sci. & Tech. Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Runlin Gao, Ph.D,MD, Fuwai Hospital and Cardiovascular Institute, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 23, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 3, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

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Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZS-01-306

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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