Study of the Survival of Recombinant Human Neuregulin-1β in Chronic Heart Failure (CHF) Patients

December 19, 2017 updated by: Zensun Sci. & Tech. Co., Ltd.

A Phase III, Multi-center,Randomized, Double-blind, Based on Standard Therapy, Placebo-controlled Study of the Survival of Recombinant Human Neuregulin-1β in Patients With Chronic Systolic Heart Failure

The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.

Study Overview

Status

Status

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

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 recent treatment. RhNRG-1(recombinant human neuregulin-1)directly work on the cardiomyocyte and restored the normal structure and function of it. Both the preclinical trial and phase II clinical trail have confirmed that rhNRG-1 effectively enhance the heart function and reverse the remodeling of left ventricular in heart failure animals and humans. In this study, we will evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.

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 (Actual)

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.
331

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 Locations

  • China
      • Beijing, China
        • Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences
      • Beijing, China
        • Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences
      • Beijing, China
        • Cardiovascular Institute and Fuwai Hospital
      • Shanghai, China
        • Huashan Hospital Affiliated to Fudan University
      • Shanghai, China
        • Renji Hospital, Medical School of Shanghai Jiaotong University
      • Shanghai, China
        • The first people's hospitial of Shanghai
      • Shanghai, China
        • The Sixth People's Hospital, Shanghai Jiaotong University
    • Beijing
      • Beijing, Beijing, China
        • General Hospital of Chinese People's Liberation Army
    • Gansu
      • Lanzhou, Gansu, China
        • The First Hospital affiliated to Lanzhou University
    • Hainan
      • Haikou, Hainan, China
        • Haikou Municipal Peoples Hospital
    • Hebei
      • Shijiazhuang, Hebei, China
        • Bethune International Peace Hospital
      • Tianjin, Hebei, China
        • Teda International Cardiovascular Hospital
    • Heilongjiang
      • Daqing, Heilongjiang, China
        • Daqing Oilfield General Hospital
      • Haerbin, Heilongjiang, China
        • The First Hospital of Harbin Medical University
    • Henan
      • Zhengzhou, Henan, China
        • The First hospital affiliated to Zhengzhou University
    • Hubei
      • Wuchang, Hubei, China
        • Zhongnan Hospital of Wuhan University
      • Wuhan, Hubei, China
        • Tongji Hospital affiliated to Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, China
        • The Second Xiangya Hospital of Central South University
      • Changsha, Hunan, China
        • Hunan Provincial People's Hospital
    • Jiangsu
      • Jiangyin, Jiangsu, China
        • Jiangsu Jiangyin People's Hospital
      • Nanjing, Jiangsu, China
        • Nanjing Drum Tower Hospital
      • Nanjing, Jiangsu, China
        • Zhongda Hospital, Southeast University
      • Suzhou, Jiangsu, China
        • The Second Hospital Affiliated To Suzhou University
      • Xuzhou, Jiangsu, China
        • The Affiliated Hospital of Xuzhou Medical School
      • Yangzhou, Jiangsu, China
        • North Jiangsu People's Hospital
      • Zhenjiang, Jiangsu, China
        • The Affiliate Hospital of Jiangsu University
    • Jilin
      • Changchun, Jilin, China
        • The Second Hospital affiliated to Jilin University
    • Liaoning
      • Dalian, Liaoning, China
        • The First Hospital affiliated to Dalian Medical University
      • Jinzhou, Liaoning, China
        • The first affiliated hospital of Liaoning medical college
      • Shenyang, Liaoning, China
        • Shengjing Hospital of China Medical University
      • Shenyang, Liaoning, China
        • Liaoning Provincial People's Hospital
      • Shenyang, Liaoning, China
        • The First Hospital of China Medical Hospital
    • Shandong
      • Jinan, Shandong, China
        • Qilu Hospital of Shandong University
      • Jinan, Shandong, China
        • The Second Hospital of Shandong University
    • Shanxi
      • Xi'an, Shanxi, China
        • Shanxi Provincial People's Hospital
      • Xi'an, Shanxi, China
        • The second hospital of Xi'an jiaotong university
    • Sichuan
      • Chendu, Sichuan, China
        • Sichuan Provincial People's Hospital
      • Chendu, Sichuan, China
        • Huaxi Hospital of Sichuan University
      • Chongqin, Sichuan, China
        • The Xinqiao Hospital of Third Military Medical University
    • Yunnan
      • Kunming, Yunnan, China
        • Kunming General Hospital of Chengdu Military Region
      • Kunming, Yunnan, China
        • The Second hospital affiliated to Kunming Medical and Pharmaceutical College
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Sir Run Run Shaw Hospital affiliated to School of Medicine, Zhejiang University
      • Hangzhou, Zhejiang, China
        • The First Hospital affiliated to School of Medicine, Zhejiang University

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age between 18 and 80, both sex.
  2. Left ventricular ejection fraction (LVEF)≤40% (ECHO).
  3. NYNA functional class III~Ⅳ.
  4. Clinical symptom is steadily in the latest 1 week (no fluid retension, no weight gain).
  5. Capable of signing the informed consent form.

Exclusion Criteria:

  1. Patients with acute pulmonary edema or acute hemodynamic disorder.
  2. Patients with right heart failure caused by pulmonary disease.
  3. Patients diagnosed with pericardial effusion or pleural effusion.
  4. Patients with myocardial infarction during the preceding 3 months.
  5. Patients with constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension.
  6. Unstable angina pectoris.
  7. Cardiac surgery or cerebrovascular accident within recent six months.
  8. Preparing for heart transplantation.
  9. Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia).
  10. Serious hepatic or renal dysfunction caused by organic pathological changes (Cr>3.0mg/dl, AST or ALT 10 times above the normal upper limit).
  11. Serum potassium <3.2 mmol/L or >5.5 mmol/L.
  12. Systolic blood pressure <90mmHg or >160mmHg.
  13. Pregnant or plan to pregnant.
  14. Patients who participated in any clinical trial in the recent three months.
  15. Subject with a life expectancy less than 3 months as assessed by the investigator.
  16. Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism).
  17. History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).
  18. Evidence (physical examination,CXR,ECHO or other tests) shows some active malignancy or adenoidal hypertrophy or neoplasm has effect on heart function or endocrine system, eg pheochromocytoma or hyperthyroidism.
  19. Judging by the investigator, the patients could not 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
Drug: placebo
day1~day10:0.6ug/kg/day,10hours per day for vein infusion; week3~week25:0.8ug/kg/day,10minutes per time per week for vein injection
Experimental: rhNRG-1
recombinant human neuregulin-1
Drug: rhNRG-1
day1~day10:0.6ug/kg/day,10hours per day for vein infusion; week3~week25:0.8ug/kg/day,10minutes per time per week for vein injection

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
Time Frame
all cause mortality
Time Frame: one year
one 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, MD,Ph.D, Cardiovascular Institute and Fuwai Hospital

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

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.
April 1, 2010

Primary Completion (Actual)

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.
June 1, 2012

Study Completion (Actual)

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.
August 1, 2012

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).
May 25, 2010

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.
May 26, 2010

First Posted (Estimate)

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.
May 27, 2010

Study Record Updates

Last Update Posted (Actual)

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.
December 21, 2017

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.
December 19, 2017

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.
July 1, 2012

More Information

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-01-301

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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