Chronic Heart FailurePhase 3NCT01439789
Study of Efficacy on NT-proBNP of Recombinant Human Neuregulin-1 in Chronic Heart Failure Patients
A Phase 3 study testing rhNRG-1 in people with Chronic Heart Failure, run by Zensun Sci. & Tech. Co., Ltd. at 21 sites in China.
Trial 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 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
- 146 participants
- Where
- 21 sitesChina
- Study dates
- Jun 2011to Jun 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 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~III.
- Definitely diagnosed with chronic systolic heart failure (including medical records, symptoms and physical signs)and clinical symptom is steadily in the latest 1 month.
- 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.
- Capable of signing the informed consent form.
Who cannot join
- Patients with acute myocardial infarction, Hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension.
- Ischemic heart failure without recanalization or with recanalization in recent six months.
- Cardiac surgery or cerebrovascular accident within recent six months.
- Preparing for heart transplantation or has received CRT treatment.
- Serious hepatic or renal dysfunction caused by organic pathological changes (Cr>2.0mg/dl, AST or ALT 5 times above the normal upper limit).
- Patients need mechanical ventilation.
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- Systolic blood pressure <90mmHg or >160mmHg.
- Patients with acute hemodynamic disorder or decompensation in the last 1 month.
- Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia).
- Serum potassium <3.2 mmol/L or >5.5 mmol/L.
- Pregnant or plan to pregnant.
- Unmarried or married but not procreated women at child-bearing age.
- Subject with a life expectancy less than 6 months as assessed by the investigator.
- Patients who participated in any clinical trial in the recent three months.
- 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
21 sites in 1 country.
21 sites in 1 country
China21 sites
Cardiovascular Institute and Fuwai Hospital
Beijing, Beijing Municipality
The Second Hospital of Jilin University
Changchun, Jilin
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Sichuan Provincial People's Hospital
Chengdu, Jiangsu
The Xinqiao Hospital of Third Military Medical University
Chongqing, 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
Qilu 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
Shanghai First People's Hospital
Shanghai, Shanghai Municipality
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality
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
Teda International Cardiovascular Hospital
Tianjin, Hebei
North Jiangsu People's Hospital
Yangzhou, Jiangsu
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
The Affiliate Hospital of Jiangsu University
Zhenjiang, Jiangsu
About this study
Official title: A Phase III, Multi-center,Randomized, Double-blind, Based on Standard Therapy, Placebo-controlled Study of the Efficacy/Safety of Recombinant Human Neuregulin-1β in Patients With Chronic Systolic Heart Failure
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.
- Conditions
- Chronic Heart Failure
- Being tested
- rhNRG-1, Placebo
- Keywords
- Chronic Heart Failure, rhNRG-1, NT-proBNP
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
PlaceboDrug
day1~day10:0.6ug/kg/day,10hours per day for vein infusion
| Study group | Role | What they receive |
|---|---|---|
| rhNRG-1 | Active comparator | Recombinant human neuregulin-1 administration in addition to basic therapy of chronic heart failure Receives: Drug: rhNRG-1 |
| Plaebo | Placebo comparator | Excipient placebo in addition to basic therapy of chronic heart failure Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
NT-proBNP
Measured: 30 days
Secondary outcomes (4)
NT-proBNP
Measured: 90 days
Six Minutes Walk Distance
Measured: 30 days and 90 days
NYHA classification
Measured: 30 days and 90 days
Quality of Life
Measured: 30 days and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: Sponsor has designed another study with different endpoint to replace the current study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zensun Sci. & Tech. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Runlin Gao, MD, Ph.D, Principal investigator, Cardiovascular Institute and Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439789
- Sponsor's protocol ID
- ZS-01-304
- Status last verified
- Jul 2012
- First submitted
- 21 Sep 2011
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multi-center,Randomized, Double-blind, Based on Standard Therapy, Placebo-controlled Study of the Efficacy/Safety of Recombinant Human Neuregulin-1β in Patients With Chronic Systolic Heart Failure
- ClinicalTrials.gov ID
- NCT01439789
- Acronym / sponsor ID
- ZS-01-304
- Conditions
- Chronic Heart Failure
- Keywords
- Chronic Heart Failure, rhNRG-1, NT-proBNP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor has designed another study with different endpoint to replace the current study
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Zensun Sci. & Tech. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 23 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rhNRG-1 | Active comparator | Drug: rhNRG-1Recombinant human neuregulin-1 administration in addition to basic therapy of chronic heart failure |
| Plaebo | Placebo comparator | Drug: PlaceboExcipient placebo in addition to basic therapy of chronic heart failure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 75, both sex.
- Left ventricular ejection fraction (LVEF)≤40% (ECHO).
- NYNA functional class II~III.
- Definitely diagnosed with chronic systolic heart failure (including medical records, symptoms and physical signs)and clinical symptom is steadily in the latest 1 month.
- 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.
Key exclusion criteria (17 listed)
- Patients with acute myocardial infarction, Hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension.
- Ischemic heart failure without recanalization or with recanalization in recent six months.
- Cardiac surgery or cerebrovascular accident within recent six months.
- Preparing for heart transplantation or has received CRT treatment.
- Serious hepatic or renal dysfunction caused by organic pathological changes (Cr>2.0mg/dl, AST or ALT 5 times above the normal upper limit).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhNRG-1day1~day10:0.6ug/kg/day,10hours per day for vein infusion | Drug | rhNRG-1 |
| Placeboday1~day10:0.6ug/kg/day,10hours per day for vein infusion | Drug | Plaebo |
Primary outcome
NT-proBNP
Time frame: 30 days
4 secondary outcomes
NT-proBNP
Time frame: 90 days
Six Minutes Walk Distance
Time frame: 30 days and 90 days
NYHA classification
Time frame: 30 days and 90 days
Quality of Life
Time frame: 30 days and 90 days
Results and safety
The study was stopped early (reason given: Sponsor has designed another study with different endpoint to replace the current study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Runlin Gao, MD, Ph.D principal investigator
Cardiovascular Institute and Fuwai Hospital
21 sites in 1 country: see every site and its status.
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 21 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 17 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 21 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 with different endpoint 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?
NT-proBNP (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.