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

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ClinicalTrials.gov Identifier: NCT03388593
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Zensun Sci. & Tech. Co., Ltd.

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 ≤1600 pg/mL and NYHA class II to III.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Drug: rhNRG-1 Drug: Placebo Phase 3

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 ≤1600 pg/mL and NYHA class II to III.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 23, 2018
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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 Name: NEUCARDIN ®




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Mortality caused by cardiovascular events [ Time Frame: 1 year ]
  2. All-cause mortality of female subjects [ Time Frame: 1 year ]
  3. All-cause mortality of male subjects [ Time Frame: 1 year ]
  4. Percentage of all-cause re-hospitalization [ Time Frame: 1 year ]
  5. Percentage of Participants with re-hospitalization caused by worsening heart failure [ Time Frame: 1 year ]
  6. Change of NT-proBNP level at the 25th week and 52th week [ Time Frame: 1 year ]
  7. New York Heart Association (NYHA) functional classification [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Age between 18 and 75, gender balance (no more than 850 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. NT-proBNP≤1600 pg/ml.
  • 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. NYNA functional class I OR IV.
  • 3. NT-proBNP>1600 pg/ml (by roche assay Kit of guangzhou jinzhe medical center).
  • 4. Patients with acute MI, hypertrophic cardiomyopathy, 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 or pleural effusion, or evidenced by B-type ultrasonic (>50ml).
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388593


Contacts
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Contact: Xiaorui Wang, Ph.D 86-21-50802627 ext 196 wangxiaorui@zensun.com
Contact: Runlin Gao, Ph.D,MD

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Sponsors and Collaborators
Zensun Sci. & Tech. Co., Ltd.
Investigators
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Principal Investigator: Runlin Gao, Ph.D,MD Fuwai Hospital and Cardiovascular Institute, Chinese Academy of Medical Sciences

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Responsible Party: Zensun Sci. & Tech. Co., Ltd.
ClinicalTrials.gov Identifier: NCT03388593     History of Changes
Other Study ID Numbers: ZS-01-306
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zensun Sci. & Tech. Co., Ltd.:
chronic heart failure
neuregulin
mortality

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases