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Chronic Systolic Heart FailurePhase 3NCT04468529

Evaluate the Effect of Injectable Neucardin on the Cardiac Function of Subjects With Chronic Systolic Heart Failure

A Phase 3 study testing Recombinant human Neuregulin for injection in people with Chronic Systolic Heart Failure, run by Zensun Sci. & Tech. Co., Ltd. at 29 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A multi-center, randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the effect of injectable Neucardin on the heart function in male patients with NT-proBNP ≤ 1700 pg/ml and female patients with NT-proBNP ≤ 4000 pg/ml, NYHA II-III chronic systolic heart failure, and to confirm its… 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?
Recombinant human Neuregulin for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
154 participants
Where
29 sitesChina
Study dates
10 Dec 2020to 7 Apr 2024
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

  • Aged 18-75 years, male or female;
  • Confirmed diagnosis of heart failure, in stable condition currently, NYHA class II-III, left ventricular ejection fraction (LVEF)≤40% (measured by echocardiography with modified Simpson's method at Screening 1, and measured by CMR at Screening 2 and baseline);
  • Male NT-proBNP ≤1700 pg/ml or female NT-proBNP≤4000 pg/ml (detected by Roche kit in the central laboratory at screening 1);
  • Receiving standard basic therapeutic medication for heart failure for more than 3 months, at the target dose or maximum tolerated dose for more than 1 month, or no change in dose within the last 1 month;
  • Understand and sign the informed consent form.

Who cannot join

  • Atrial fibrillation during the screening period;
  • Conditions limiting CMR examination, such as installation of pacemakers, ICDs, CRTs or other similar devices contraindicated for CMR, or have claustrophobia;
  • Hypertrophic cardiomyopathy with outflow tract obstruction, constrictive pericarditis, significant and uncorrected valvular heart disease (severe regurgitation or severe stenosis or valvular disease requiring surgery), congenital heart disease requiring surgery but not yet undergoing surgical treatment, primary pulmonary hypertension or secondary severe pulmonary hypertension (≥ 70 mmHg);
  • Right heart failure due to lung disease;
  • Subjects with chronic heart failure complicated with acute hemodynamic disturbance or acute decompensation within recent 1 month (symptoms and signs indicate chronic heart failure is aggravated, and intravenous drug therapy may be required);
  • Angina pectoris within 3 months;
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  • Myocardial infarction within the past 6 months;
  • Cerebrovascular accident, revascularization (PCI or other surgery), cardiac surgery, carotid artery or other large vessel surgery within the past 6 months;
  • Prepare to install pacemaker, ICD, CRT or other similar devices within 6 months;
  • History of heart transplantation, use of ventricular assist device (VAD) or preparation for heart transplantation, VAD;
  • Diagnosis of peripartum or chemotherapy-induced cardiomyopathy within the past 12 months;
  • Serious arrhythmia (sustained ventricular tachycardia or other conditions meet the criteria according to the investigator's judgement );
  • Clinical diagnosis of pericardial effusion, pleural effusion or B ultrasound showed pericardial effusion (greater than 50ml or 3 mm) or pleural effusion (greater than 200ml or 10 mm);
  • Liver or kidney dysfunction, chronic liver disease may have a potential impact on liver function, non-heart failure induced bilirubin or alkaline phosphatase > 2 times the upper limit of normal, aspartate aminotransferase or alanine aminotransferase > 3 times the upper limit of normal, eGFR calculated using the MDRD method < 30 ml/min/1.73m2 ;
  • Systolic blood pressure < 90 mmHg or > 160 mmHg;
  • Blood K + < 3.2 mmol/L or > 5.5 mmol/L;
  • Subjects with an absolute change in LVEF > 5% as detected by CMR between screening 2 and baseline;
  • Women of childbearing age who are planning to become pregnant within 2 years (women of childbearing age are defined as all women with physiological capability to become pregnant), and pregnant or lactating women;
  • Patients whose survival time is expected to be less than 6 months as judged by the investigator;
  • Those who have participated in any drug clinical trial within the previous 3 months;
  • Severe neurological disorders (Alzheimer's disease, progressive parkinsonism);
  • The subjects with tumor history or is suffering from tumor now, or with precancerous lesions confirmed by pathological examination (such as breast ductal carcinoma in situ, or cervical dysplasia), or with malignant mass found by examination (physical examination, X-ray examination or B ultrasound examination or other means);
  • The subjects with proliferative glands or adenomas that are found to have endocrine activity that affects cardiac function or endocrine function detected by examinations (physical examination, X-ray examination, B ultrasound examination or other means), such as pheochromocytoma, thyromegaly, etc. (patients with euthyroid thyroid or normal thyroid function do not need to be excluded);
  • The subject, in the judgment of the Investigator, is unable to complete the study or to comply with the requirements of the study (for administrative or other reasons).

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

China29 sites

  • Beijing Chaoyang Hospital of Capital Medical University

    Beijing

  • Beijing Friendship Hospital of Capital Medical University

    Beijing

  • Chinese PLA General Hospital

    Beijing

  • Fuwai hospital chinese Academy of Medical Sciences

    Beijing

  • China-Japan Union Hospital of Jilin University

    Changchun

  • The First Hospital of Jilin University

    Changchun

  • The Second Xiangya Hospital of Central South University

    Changsha

  • Chongqing University Three Gorges Hospital

    Chongqing

  • The First Affiliated Hospital of Dalian Medical University

    Dalian

  • First Affiliated Hospital,Sun Yat-sen University

    Guangzhou

  • Guangdong Provincial People's Hospital

    Guangzhou

  • Haikou People's Hospital

    Haikou

  • Hainan General Hospital

    Hainan

  • Hunan Provincial People's Hospital

    Hunan

  • Jinan Central Hospital

    Jinan

  • Qilu Hospital of Shandong University

    Jinan

  • Shandong Province QianFoshan Hospital

    Jinan

  • Luoyang Center Hospital

    Luoyang

  • Affiliated Drum Tower Hospital, Medical School of Nanjing University

    Nanjing

  • Shanghai First People's Hospital

    Shanghai

  • Shanghai JiaoTong University Ruijing Hospital

    Shanghai

  • Shanghai Putuo District Central Hospital

    Shanghai

  • Shengjing Hospital of China Medical University

    Shenyang

  • The First Affiliated Hospital of Soochow University

    Suzhou

  • First Hospital of Shanxi Medical University

    Taiyuan

  • Shanxi Cardiovascular Hospital

    Taiyuan

  • People's Hospital of Tianjin

    Tianjin

  • The Second Hospital of Tianjin Medical University

    Tianjin

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

Other trials in China

About this study

Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Effect of Injectable Neucardin on the Cardiac Function of Subjects With Chronic Systolic Heart Failure on Standard Heart Failure Therapy

A multi-center, randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the effect of injectable Neucardin on the heart function in male patients with NT-proBNP ≤ 1700 pg/ml and female patients with NT-proBNP ≤ 4000 pg/ml, NYHA II-III chronic systolic heart failure, and to confirm its efficacy and safety.

Read the detailed description

This trial is planned to be conducted simultaneously in multiple domestic clinical research site, and a total of 140 subjects will be enrolled, including 70 subjects in the investigational drug group and 70 subjects in the placebo group.

Primary endpoint: LVESVI change from baseline on day 30 Secondary endpoints: LVEF Change from baseline on day 30 and day 90. LVESV, LVEDV, LVEDVI change from baseline on day 30. LVESV, LVESVI, LVEDV, LVEDVI change from baseline on day 90. NT-proBNP change from baseline on day 30 and day 90. NYHA class change from baseline on day 30 and day 90.

Being tested
Recombinant human Neuregulin for injection, Placebo

What participants receive

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

  • Recombinant human Neuregulin for injectionDrug

    Also called Neucardin

    10 hours per day i.v. drip for the first 10 days (0.6ug/kg/day)

  • PlaceboDrug

    10 hours per day i.v. drip for the first 10 days (0ug/kg/day)

Study groups in NCT04468529
Study groupRoleWhat they receive
Investigational drug groupExperimentalInjectable Neucardin + standard basic therapeutic medication
Receives: Drug: Recombinant human Neuregulin for injection
Placebo groupPlacebo comparatorplacebo + standard basic therapeutic medication
Receives: Drug: Placebo

What is being measured

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

  1. Left Ventricular End-Systolic Volume Index(LVESVI) change from baseline on day 30

    Left Ventricular End-Systolic Volume Index(LVESVI) change from baseline

    Measured: Day 30

Secondary outcomes (7)

  1. Left Ventricular Ejection Fraction(LVEF) Change from baseline on day 30 and day 90

    Left Ventricular Ejection Fraction(LVEF) Change from baseline

    Measured: Day 30 and Day 90

  2. Left Ventricular End-Systolic Volume Index(LVESVI) change from baseline on day 90

    Left Ventricular End-Systolic Volume Index(LVESVI) change from baseline

    Measured: Day 90

  3. Left Ventricular End-Systolic Volume(LVESV)change from baseline on day 30 and day 90

    Left Ventricular End-Systolic Volume(LVESV)change from baseline

    Measured: Day 30 and Day 90

  4. Left Ventricular End-Diastolic Volume(LVEDV)change from baseline on day 30 and day 90

    Left Ventricular End-Diastolic Volume(LVEDV)change from baseline

    Measured: Day 30 and Day 90

  5. Left Ventricular End-Diastolic Volume Index(LVEDVI )change from baseline on day 30 and day 90

    Left Ventricular End-Diastolic Volume Index(LVEDVI )

    Measured: Day 30 and Day 90

  6. N-Terminal pro-Brain Natriuretic Peptide(NT-proBNP) change from baseline on day 30 and day 90

    N-Terminal pro-Brain Natriuretic Peptide(NT-proBNP) change from baseline

    Measured: Day 30 and Day 90

  7. New York Heart Association(NYHA) class change from baseline on day 30 and day 90

    New York Heart Association(NYHA) class change from baseline

    Measured: Day 30 and day 90

Timeline

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

  1. First posted13 Jul 2020
  2. Study start10 Dec 2020
  3. Primary completion12 Apr 2022
  4. Study completion7 Apr 2024

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
Model description
This is a multi-center, randomized, double-blind, standard therapy based, placebo-controlled parallel study.
Masking
Single blind
Who is masked
Participant
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04468529
Sponsor's protocol ID
ZS-01-308
Status last verified
Feb 2022
First submitted
6 Jul 2020
Last updated
25 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Zensun ensures that the key information about the design of this protocol will be published in a publicly available database such as www.clinicaltrials.gov. After the end of the trial, Zensun will assist the study site to objectively summarize the trial results, use appropriate statistical methods to analyze the trial data, objectively evaluate the safety and efficacy of the drug according to the results, and make a complete written summary report of the clinical trial. Study results will be submitted for publication and/or publication in a publicly available database. If other individuals or institutions related to this study want to publish or publish the study results or related data, they need to obtain the consent of the sponsor in advance. If the sponsor needs to include the name of the investigators in any publication or advertisement, the consent of the investigator should be obtained.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Recombinant human Neuregulin for injection in people with Chronic Systolic Heart Failure, run by Zensun Sci. & Tech. Co., Ltd. at 29 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 24 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: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 End-Systolic Volume Index(LVESVI) change from baseline on day 30 (time frame: Day 30). 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 NCT04468529.

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 25 Jul 2024.

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