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

Last updated: December 19, 2017
Sponsor: Zensun Sci. & Tech. Co., Ltd.
Overall Status: Terminated

Phase

3

Condition

Congestive Heart Failure

Chest Pain

Heart Failure

Treatment

N/A

Clinical Study ID

NCT01439789
ZS-01-304
  • Ages 18-75
  • All Genders

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.

Eligibility Criteria

Inclusion

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 dosageor the highest tolerated dosage for at least 1 month, or the dosage has not beenchanged for at least 1 month.

  6. Capable of signing the informed consent form.

Exclusion

Exclusion Criteria:

  1. Patients with acute myocardial infarction, Hypertrophic cardiomyopathy, constrictivepericarditis, significant valvular pathological change or congenital heart diseases,severe pulmonary artery hypertension.

  2. Ischemic heart failure without recanalization or with recanalization in recent sixmonths.

  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-malignantcondition (eg DICS or cervical atypia).

  16. Evidence (physical examination,CXR,ECHO or other tests) shows some active malignancyor 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 tothe study requirements (due to the management reasons or others).

Study Design

Total Participants: 146
Study Start date:
June 01, 2011
Estimated Completion Date:
June 30, 2012

Study 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.

Connect with a study center

  • Cardiovascular Institute and Fuwai Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong
    China

    Site Not Available

  • Bethune Peace Hospital

    Shijiazhuang, Hebei
    China

    Site Not Available

  • Teda International Cardiovascular Hospital

    Tianjin, Hebei
    China

    Site Not Available

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang
    China

    Site Not Available

  • The First Hospital of Harbin Medical University

    Haerbin, Heilongjiang
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan
    China

    Site Not Available

  • Sichuan Provincial People`s Hospital

    Chengdu, Jiangsu
    China

    Site Not Available

  • The Second Hospital affiliated to Suzhou University

    Suzhou, Jiangsu
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical School

    Xuzhou, Jiangsu
    China

    Site Not Available

  • North Jiangsu People's Hospital

    Yangzhou, Jiangsu
    China

    Site Not Available

  • The Affiliate Hospital of Jiangsu University

    Zhenjiang, Jiangsu
    China

    Site Not Available

  • The Second Hospital of Jilin University

    Changchun, Jilin
    China

    Site Not Available

  • The First Hospital affiliated to Dalian Medical University

    Dalian, Liaoning
    China

    Site Not Available

  • The first affiliated hospital of Liaoning medical college

    Jinzhou, Liaoning
    China

    Site Not Available

  • Liaoning Provincial People's Hospital

    Shenyang, Liaoning
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong
    China

    Site Not Available

  • Shanghai First People's Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • The Xinqiao Hospital of Third Military Medical University

    Chongqing, Sichuan
    China

    Site Not Available

  • Kunming General Hospital of Chengdu Military Region

    Kunming, Yunnan
    China

    Site Not Available

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