Chronic Systolic Heart FailurePhase 3NCT01439893
Study of Efficacy on Cardiac Remodeling of Recombinant Human Neuregulin-1 in Stable Chronic Systolic Heart Failure Patients
A Phase 3 study testing rhNRG-1 in people with Chronic Systolic Heart Failure, run by Zensun Sci. & Tech. Co., Ltd. at 4 sites in China.
Trial summary
This is a 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 cardiac remodeling, 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 Systolic 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
- 14 participants
- Where
- 4 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 atrial fibrillation.
- Patients with a pacemaker.
- Patient with a metallic implant.
- Patient with Claustrophobia.
- 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.
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- 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.
- 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
4 sites in 1 country.
China4 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
Cardiovascular Institute and Fuwai Hospital
Beijing, Beijing Municipality
General Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality
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
This is a 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 cardiac remodeling, as well as safety in patients with chronic heart failure.
Read the detailed description
RhNRG-1(recombinant human neuregulin-1)directly works on the cardiomyocytes and restored the normal structure and function of it.Both the preclinical trial and phase II clinical trail have confirmed that rhNRG-1 effectively improved the heart function, and is tolerated in the effective dosage groups. The aim of this phase III trial is to further confirm in large population that rhRNG-1 administration can effectively improve the cardiac remodeling and is tolerated in patients with chronic heart failure.
- Conditions
- Chronic Systolic Heart Failure
- Being tested
- rhNRG-1, Placebo
- Keywords
- Chronic heart failure, rhNRG-1, Cardiac remodeling
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 |
| Placebo | 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.
Left Ventricular Ejection Fraction
Measured: 30 days
Secondary outcomes (2)
Left Ventricular Ejection Fraction
Measured: 90 days
N-terminal pro-BNP
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 Systolic 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
- 14 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
- NCT01439893
- Sponsor's protocol ID
- ZS-01-303
- 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
- NCT01439893
- Acronym / sponsor ID
- ZS-01-303
- Conditions
- Chronic Systolic Heart Failure
- Keywords
- Chronic heart failure, rhNRG-1, Cardiac remodeling
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor has designed another study with different endpoint to replace the current study
- Enrolment
- 14 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.
This is a 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 cardiac remodeling, as well as safety in patients with chronic heart failure.
Detailed description
RhNRG-1(recombinant human neuregulin-1)directly works on the cardiomyocytes and restored the normal structure and function of it.Both the preclinical trial and phase II clinical trail have confirmed that rhNRG-1 effectively improved the heart function, and is tolerated in the effective dosage groups. The aim of this phase III trial is to further confirm in large population that rhRNG-1 administration can effectively improve the cardiac remodeling 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 |
| Placebo | 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 (21 listed)
- Patients with atrial fibrillation.
- Patients with a pacemaker.
- Patient with a metallic implant.
- Patient with Claustrophobia.
- Patients with acute myocardial infarction, Hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension.
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 | Placebo |
Primary outcome
Left Ventricular Ejection Fraction
Time frame: 30 days
2 secondary outcomes
Left Ventricular Ejection Fraction
Time frame: 90 days
N-terminal pro-BNP
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
4 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 Systolic Heart Failure, run by Zensun Sci. & Tech. Co., Ltd. at 4 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 21 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 4 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?
Left Ventricular Ejection Fraction (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.