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Chronic Heart FailurePhase 3NCT01131637

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

A Phase 3 study testing rhNRG-1 in people with Chronic Heart Failure, run by Zensun Sci. & Tech. Co., Ltd. at 43 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chronic Heart Failure
What is being tested?
rhNRG-1
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
331 participants
Where
43 sitesChina
Study dates
Apr 2010to Aug 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Patients with acute pulmonary edema or acute hemodynamic disorder.
  • Patients with right heart failure caused by pulmonary disease.
  • Patients diagnosed with pericardial effusion or pleural effusion.
  • Patients with myocardial infarction during the preceding 3 months.
  • Patients with constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension.
  • Unstable angina pectoris.
Show all 19Show fewer
  • Cardiac surgery or cerebrovascular accident within recent six months.
  • Preparing for heart transplantation.
  • Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia).
  • Serious hepatic or renal dysfunction caused by organic pathological changes (Cr>3.0mg/dl, AST or ALT 10 times above the normal upper limit).
  • Serum potassium <3.2 mmol/L or >5.5 mmol/L.
  • Systolic blood pressure <90mmHg or >160mmHg.
  • Pregnant or plan to pregnant.
  • Patients who participated in any clinical trial in the recent three months.
  • Subject with a life expectancy less than 3 months as assessed by the investigator.
  • Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism).
  • History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).
  • 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.
  • Judging by the investigator, the patients could not complete the study or adhere to the study requirements (due to the management reasons or others).

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

China43 sites

  • General Hospital of Chinese People's Liberation Army

    Beijing, Beijing Municipality

  • Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences

    Beijing

  • Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences

    Beijing

  • Cardiovascular Institute and Fuwai Hospital

    Beijing

  • The Second Hospital affiliated to Jilin University

    Changchun, Jilin

  • Hunan Provincial People's Hospital

    Changsha, Hunan

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

  • Huaxi Hospital of Sichuan University

    Chengdu, Sichuan

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan

  • The Xinqiao Hospital of Third Military Medical University

    Chongqin, Sichuan

  • The First Hospital affiliated to Dalian Medical University

    Dalian, Liaoning

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang

  • The First Hospital of Harbin Medical University

    Haerbin, Heilongjiang

  • Haikou Municipal Peoples Hospital

    Haikou, Hainan

  • Sir Run Run Shaw Hospital affiliated to School of Medicine, Zhejiang University

    Hangzhou, Zhejiang

  • The First Hospital affiliated to School of Medicine, Zhejiang University

    Hangzhou, Zhejiang

  • Jiangsu Jiangyin People's Hospital

    Jiangyin, Jiangsu

  • Qilu Hospital of Shandong University

    Jinan, Shandong

  • The Second Hospital of Shandong University

    Jinan, Shandong

  • The first affiliated hospital of Liaoning medical college

    Jinzhou, Liaoning

  • Kunming General Hospital of Chengdu Military Region

    Kunming, Yunnan

  • The Second hospital affiliated to Kunming Medical and Pharmaceutical College

    Kunming, Yunnan

  • The First Hospital affiliated to Lanzhou University

    Lanzhou, Gansu

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu

  • Zhongda Hospital, Southeast University

    Nanjing, Jiangsu

  • Huashan Hospital affiliated to Fudan University

    Shanghai

  • Renji Hospital, Medical School of Shanghai Jiaotong University

    Shanghai

  • The first people's hospitial of Shanghai

    Shanghai

  • The Sixth People's Hospital, Shanghai Jiaotong University

    Shanghai

  • Liaoning Provincial People's Hospital

    Shenyang, Liaoning

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

  • The First Hospital of China Medical Hospital

    Shenyang, Liaoning

  • Bethune International Peace Hospital

    Shijiazhuang, Hebei

  • The Second Hospital affiliated to Suzhou University

    Suzhou, Jiangsu

  • Teda International Cardiovascular Hospital

    Tianjin, Hebei

  • Zhongnan Hospital of Wuhan University

    Wuchang, Hubei

  • Tongji Hospital Affiliated to Huazhong University of Science and Technology

    Wuhan, Hubei

  • Shanxi Provincial People's Hospital

    Xi’an, Shanxi

  • The second hospital of Xi'an jiaotong university

    Xi’an, Shanxi

  • The Affiliated Hospital of Xuzhou Medical School

    Xuzhou, Jiangsu

  • North Jiangsu People's Hospital

    Yangzhou, Jiangsu

  • The First hospital affiliated to Zhengzhou University

    Zhengzhou, Henan

  • The Affiliate Hospital of Jiangsu University

    Zhenjiang, Jiangsu

Other trials in China

About this study

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

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

Read the 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.

Being tested
rhNRG-1, placebo
Keywords
chronic heart failure, rhNRG-1, mortality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rhNRG-1Drug

    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

  • placeboDrug

    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

Study groups in NCT01131637
Study groupRoleWhat they receive
rhNRG-1Experimentalrecombinant human neuregulin-1
Receives: Drug: rhNRG-1
placeboPlacebo comparatorplacebo
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. all cause mortality

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionJun 2012
  4. Study completionAug 2012

Why it stopped: Sponsor has designed another study to replace the current study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
331 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01131637
Sponsor's protocol ID
ZS-01-301
Status last verified
Jul 2012
First submitted
25 May 2010
Last updated
21 Dec 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rhNRG-1 in people with Chronic Heart Failure, run by Zensun Sci. & Tech. Co., Ltd. at 43 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor has designed another study to replace the current study). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

all cause mortality (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01131637.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2017.

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