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TerminatedNCT01439789Updated Dec 21, 2017

Study of Efficacy on NT-proBNP of Recombinant Human Neuregulin-1 in Chronic Heart Failure Patients

A Phase 3 interventional study of rhNRG-1 and Placebo in Chronic Heart Failure, sponsored by Zensun Sci. & Tech. Co., Ltd.. Terminated at 21 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-12-21.

Sponsored by Zensun Sci. & Tech. Co., Ltd. · Phase 3, Interventional, and Treatment

Why this study was terminated
Sponsor has designed another study with different endpoint to replace the current study
Phase
Phase 3
Study type
Interventional
Enrollment
146
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study summary

Multi-center, randomized, double-blind , placebo parallel controlled, standard therapy based phase III clinical trial, to evaluate the efficacy of recombinant human neuregulin-1 on serum NT-proBNP, as well as safety in patients with chronic heart failure.

Read the detailed description

N-terminal proNBP (NT-proBNP) has been proved to be an independent prognostic factor for the long-term prognosis of chronic heart failure patients.RhNRG-1(recombinant human neuregulin-1)directly works on the cardiomyocytes and restored the normal structure and function of it. It has been found that rhNRG-1 effectively decreased the serum level of NT-proBNP,and is tolerated in the effective dosages groups.The aim of this phase III trial is to further confirm in large population that rhRNG-1 administration can effectively decrease the serum level of NT-proBNP and is tolerated in patients with chronic heart failure.

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Conditions studied

  • Chronic Heart Failure

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Keywords

  • Chronic Heart Failure
  • rhNRG-1
  • NT-proBNP
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 146 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Zensun Sci. & Tech. Co., Ltd. is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age between 18 and 75, both sex.
  2. Left ventricular ejection fraction (LVEF)≤40% (ECHO).
  3. NYNA functional class II\~III.
  4. Definitely diagnosed with chronic systolic heart failure (including medical records, symptoms and physical signs)and clinical symptom is steadily in the latest 1 month.
  5. Receiving standard basic treatment of heart failure, has reached the objective dosage or the highest tolerated dosage for at least 1 month, or the dosage has not been changed for at least 1 month.
  6. Capable of signing the informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Patients with acute myocardial infarction, Hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension.
  2. Ischemic heart failure without recanalization or with recanalization in recent six months.
  3. Cardiac surgery or cerebrovascular accident within recent six months.
  4. Preparing for heart transplantation or has received CRT treatment.
  5. Serious hepatic or renal dysfunction caused by organic pathological changes (Cr>2.0mg/dl, AST or ALT 5 times above the normal upper limit).
  6. Patients need mechanical ventilation.
  7. Systolic blood pressure \<90mmHg or >160mmHg.
  8. Patients with acute hemodynamic disorder or decompensation in the last 1 month.
  9. Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia).
  10. Serum potassium \<3.2 mmol/L or >5.5 mmol/L.
  11. Pregnant or plan to pregnant.
  12. Unmarried or married but not procreated women at child-bearing age.
  13. Subject with a life expectancy less than 6 months as assessed by the investigator.
  14. Patients who participated in any clinical trial in the recent three months.
  15. History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).
  16. 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.
  17. Judging by the investigator, the patients could not complete the study or adhere to the study requirements (due to the management reasons or others).
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
146 participants (actual)

Study arms

  • Active comparator
    rhNRG-1

    Recombinant human neuregulin-1 administration in addition to basic therapy of chronic heart failure

    Drug: rhNRG-1

  • Placebo comparator
    Plaebo

    Excipient placebo in addition to basic therapy of chronic heart failure

    Drug: Placebo

Interventions

  • DrugrhNRG-1

    day1\~day10:0.6ug/kg/day,10hours per day for vein infusion

  • DrugPlacebo

    day1\~day10:0.6ug/kg/day,10hours per day for vein infusion

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What researchers measure

Primary outcomes

  1. NT-proBNP

    Time frame: 30 days

Secondary outcomes

  1. NT-proBNP

    Time frame: 90 days

  2. Six Minutes Walk Distance

    Time frame: 30 days and 90 days

  3. NYHA classification

    Time frame: 30 days and 90 days

  4. Quality of Life

    Time frame: 30 days and 90 days

07

Study locations

21 sites
  • Cardiovascular Institute and Fuwai Hospital
    Beijing, Beijing, China
  • Bethune Peace Hospital
    Shijiazhuang, Hebei, China
  • Teda International Cardiovascular Hospital
    Tianjin, Hebei, China
  • Daqing Oilfield General Hospital
    Daqing, Heilongjiang, China
  • The First Hospital of Harbin Medical University
    Haerbin, Heilongjiang, China
  • The First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan, China
  • The Second Xiangya Hospital of Central South University
    Changsha, Hunan, China
  • Sichuan Provincial People's Hospital
    Chengdu, Jiangsu, China
  • The Second Hospital affiliated to Suzhou University
    Suzhou, Jiangsu, China
  • North Jiangsu People's Hospital
    Yangzhou, Jiangsu, China
  • The Affiliate Hospital of Jiangsu University
    Zhenjiang, Jiangsu, China
  • The Second Hospital of Jilin University
    Changchun, Jilin, China
  • The First Hospital affiliated to Dalian Medical University
    Dalian, Liaoning, China
  • The first affiliated hospital of Liaoning medical college
    Jinzhou, Liaoning, China
  • Liaoning Provincial People's Hospital
    Shenyang, Liaoning, China
  • Shengjing Hospital of China Medical University
    Shenyang, Liaoning, China
  • Qilu Hospital of Shandong University
    Jinan, Shandong, China
  • Shanghai First People's Hospital
    Shanghai, Shanghai, China
  • Shanghai Sixth People's Hospital
    Shanghai, Shanghai, China
  • The Xinqiao Hospital of Third Military Medical University
    Chongqing, Sichuan, China
  • Kunming General Hospital of Chengdu Military Region
    Kunming, Yunnan, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01439789
Lead sponsor
Zensun Sci. & Tech. Co., Ltd.
Responsible party
Sponsor
First posted
Sep 23, 2011
Start date
Jun 2011
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Dec 21, 2017

Study contacts

Runlin Gao, MD, Ph.D
principal investigator · Cardiovascular Institute and Fuwai Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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