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Chronic Heart FailurePhase 3NCT01541202

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 46 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 75 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
679 participants
Where
46 sitesChina
Study dates
Feb 2012to Aug 2017
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 75, both sex.
  • Left ventricular ejection fraction (LVEF)≤40% (ECHO).
  • NYNA functional class II OR III.
  • Diagnosed as chronic systolic heart failure (history, symptoms, signs), no in-hospital history in the last one month.
  • Receiving standard therapy for chronic heart failure, reach target dose or max tolerable dose for one month, or has not changed the dose for the last one month.
  • Capable of signing the informed consent form.

Who cannot join

  • new chronic heart failure patients, or patients receiving standard therapy on chronic heart failure for less than 3 months.
  • NYNA functional class I OR IV.
  • Patients with acute MI, hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, primary or secondary severe pulmonary artery hypertension.
  • Ischemic heart failure without recanalization or with recanalization in recent six months.
  • acute MI in the last 3 months.
  • unstable angina.
Show all 23Show fewer
  • Patients with acute pulmonary edema or acute hemodynamic disorder.
  • Chronic heart failure patients with acute hemodynamic disorder or acute decompensation in the last 1 month.
  • Patients with right heart failure caused by pulmonary disease.
  • Patients diagnosed with pericardial effusion or pleural effusion, or evidenced by B-type ultrasonic (>50ml).
  • Cardiac surgery or cerebrovascular accident within recent six months.
  • Preparing for heart transplantation or CRT, or has received CRT.
  • Serious ventricular arrhythmia (multi-morphological premature ventricular contraction more than 5 times/min, frequent paroxysmal ventricular tachycardia or triple rate).
  • Serious hepatic or renal dysfunction (Cr>2.0mg/dl, AST or ALT 5 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 6 months as assessed by the investigator.
  • Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism),lower limb defects, or deaf-mute.
  • 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

46 sites in 1 country.

46 sites in 1 country

China46 sites

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

    Beijing, Beijing Municipality

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

    Beijing, Beijing Municipality

  • Beijing Xuanwu hospital of Capital Medical University

    Beijing, Beijing Municipality

  • Cardiovascular Institute and Fuwai Hospital

    Beijing, Beijing Municipality

  • General Hospital of Chinese People's Liberation Army

    Beijing, Beijing Municipality

  • Peking University First Hospital

    Beijing, Beijing Municipality

  • The Second Hospital affiliated to Jilin University

    Changchun, Jilin

  • People's Hospital of Hunan Province

    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

    Chongqing, Chongqing Municipality

  • The First Hospital affiliated to Dalian Medical University

    Dalian, Liaoning

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang

  • Fujian Provincial Hospital

    Fuzhou, Fujian

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

  • The First Affiliated Hospital, Sun Yet-Sen University

    Guangzhou, Guangdong

  • 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

  • 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 of Kunming Medical College

    Kunming, Yunnan

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu

  • Zhongda Hospital, Southeast University

    Nanjing, Jiangsu

  • Huashan Hospital affiliated to Fudan University

    Shanghai, Shanghai Municipality

  • Renji Hospital, Medical School of Shanghai Jiaotong University

    Shanghai, Shanghai Municipality

  • Ruijin Hospital, Medical School of Shanghai Jiaotong University

    Shanghai, Shanghai Municipality

  • The first people's hospitial of Shanghai

    Shanghai, Shanghai Municipality

  • The Sixth People's Hospital, Shanghai Jiaotong University

    Shanghai, Shanghai Municipality

  • The First Hospital of China Medical College

    Shengyang, Liaoning

  • Liaoning Provincial People's Hospital

    Shenyang, Liaoning

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

  • Bethune Peace Hospital

    Shijiazhuang, Hebei

  • The Second Hospital affiliated to Suzhou University

    Suzhou, Jiangsu

  • The Second Hospital of Shanxi Medical College

    Taiyuan, Shanxi

  • Teda International Cardiovascular Hospital

    Tianjin, Hebei

  • Tongji Hospital Affiliated to Huazhong University of Science and Technology

    Wuhan, Hubei

  • 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 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 trial and phase II clinical trail 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. In this phase III study, the investigators will further confirm the efficacy of rhNRG-1 in reducing the death rate of heart failure.

Being tested
rhNRG-1, Placebo
Keywords
chronic heart failure, neuregulin, mortality
Medical subject headings
Fibromatosis, Gingival, 2

What participants receive

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

  • rhNRG-1Drug

    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

  • PlaceboDrug

    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

Study groups in NCT01541202
Study groupRoleWhat they receive
PlaceboPlacebo comparatorplacebo in addition to standard therapy
Receives: Drug: Placebo
rhNRG-1ExperimentalrhNRG-1 in addition to standard therapy
Receives: Drug: rhNRG-1

What is being measured

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

  1. All-cause mortality

    Measured: 1 year

Secondary outcomes (8)

  1. sudden death

    Measured: 1 year

  2. death caused by cardiovascular events

    Measured: 1 year

  3. rehospitalization

    Measured: 1 year

  4. hospitalization caused by worsening heart failure

    Measured: 1 year

  5. cardiac function

    Measured: 1 year

  6. NYHA functional classification

    Measured: 1 year

  7. 6 minute walking distance

    Measured: 1 year

  8. quality of life

    Measured: 1 year

Timeline

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

  1. First posted29 Feb 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionAug 2017
  4. Study completionAug 2017

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
679 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01541202
Sponsor's protocol ID
ZS-01-305
Status last verified
Feb 2012
First submitted
23 Feb 2012
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 46 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 6 inclusion and 23 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 46 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: 1 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 NCT01541202.

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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